| APPLICATION RECEIVED FOR REGISTRATION TO IMPORT DRUGS DURING YEAR 2007-08 | |||||||
| Month: December 2007 | |||||||
| S.No. | Date of Submission | Application Concerned (BD/FF) | Nature of Application (Fresh, Endorsement, Renewal) | RC No. & Date of Expiry | Name and address of Indian agent | Name and address of manufacturing site to be registered | Name of Drugs |
| 1 | 03/12/2007 | BD | Renewal | BD-506 28/2/2011 | Nayyar Medicine Co., Delhi | Changshu Wanxing Chemical Co., Ltd., China | Alpha Lipoic Acid USP/EP |
| 2 | 03/12/2007 | FF | Endorsement | FF-107 31/12/2008 | Sanofi-Synthelabo (India) Ltd.,Mumbai | Sanofi Wintrop Industries 1, Rue de la Vierge, Ambras Et Lagrave 33565 Carbon Blanc Cedex, France | Co Aprvel 300/25 (Irbesartan + Hydrochlorothiazide |
| 3 | 03/12/2007 | FF | Renewal | FF-346 31/08/2008 | Astrazeneca Pharma India Limited, Bangalore | AstraZeneca GmbH, Niederlasung Plankstadt, Otto-hanh strasse, 68723, plankstadt, Germany | Casodex 50mg |
| 4 | 10/12/2007 | BD | Endorsement | BD-388 31/03/2010 | Nayyar Medicine Co., Delhi | Xianju Hongyan Pharmaceuticals Chemicals Co., Ltd., China | Medroxy Progesterone Acetate USP/BP/EP |
| 5 | 10/12/2007 | FF | Fresh | Medi Globe, New Delhi | PH & T, SPA, VIA L.Aristo, 34, 20145 Milan, Italy | Somatostatine 3mg/2ml | |
| 6 | 11/12/2007 | FF | Fresh | Medi Globe, New Delhi | Gelfipharma International SRL Via Emilia 99/A-26900 LODT, Italy | Nitroglycerine 25mg/5ml | |
| 7 | 11/12/2007 | FF | Re-registration | FF-347 31/08/2008 | Roche Scientific Company (India) Pvt. Ltd., Mumbai | Roche Pharma S.A, Spain | Saquinavir Mesylate |
| 8 | 12/12/2007 | FF | Fresh | Ranbaxy Laboratories Limited,Punjab | MGI Pharma, USA | Polifeprosan 20 with Carmustine Implant | |
| 9 | 17/12/2007 | BD | Re-registration | BD-417,31/5/2007 | Chemet, Mumbai | Pharmasynthese, 57, Rue Gravetel-BP 3, 76320 Saint-Pierre-Les-Elbeuf, France | 1.Cinchocaine Base 2.Cinchocaine HCL |
| 10 | 19/12/2007 | BD | Endorsement | BD-258 31/08/2009 | Ruskin Chemipharma, Mumbai | Jiangsu Hengrui Co. Limited, China | Cisatracurium Besilate |
| 10 | 20/12/007 | FF | Fresh | Medi Globe, New Delhi | Eriochem S.A, Argentina | Leuprolide acetate depot 3.75mg and 11.25mg Injection | |
| 11 | 24/12/2007 | BD | Fresh | Nayyar Medicine Co., Delhi | Changzhou Yinsheng Pharmaceutical Co., Ltd., China | Tranexamic Acid BP | |
| 12 | 24/12/2007 | FF | Renewal | FF-311 31/1/2008 | Solvay Pharma India Ltd.,Mumbai | Solvay Pharmaceuticals B.V., Veerweg 12, 8121 A A Olst, The Netherland | Mebeverine Hydrochloride Sustained Release Granules |
| 13 | 26/12/2007 | FF | Endorsement | FF-88 31/8/07 | Boehringer Ingelhelm India Private Ltd., Mumbai | Boehringer Ingelheim Pharma GmbH & Co. KG, Germany | Telmisartan Granulates |
| 14 | 28/12/2007 | BD | Re-registration | BD-551 30/06/2008 | Chr Hansen (india) Pvt. Ltd., Maharashtra | Chr. Hansen A/S, Denmark | 1. Beta Carotene (WS) 2. Beta Carotene (OS) 3.Probio-Tec AB-Blend 10 4.Urex-Blend |
| 15 | 31/12/2007 | FF | Re-registration | FF-345 31/08/2008 | Criticare Pharma Pvt. Ltd., Mumbai | CSL Behring GmbH, Germany | Streptokinase Injection 750,000 IU & 1500 000 IU |
| 16 | 31/12/2007 | FF | Endorsement | FF-134 31/05/2007 | J&J Limited, Mumbai | Closure Medical Corporation, USA | Prineo Skin Closure System |
| 17 | 31/12/2007 | FF | Fresh | FF-458,31/03/2011 | Novartis India Limited, Mumbai | LTS Lohmann Therapie System AG, Lohmannstrasse 2, 56626 Andrnach, Germany | Exleon Patch(Rivastigmine Transdermal Patch) |
| 18 | 31/12/2007 | FF | Fresh | FF-451,31/1/2008 | VHB LifeSciences, Mumbai | Hangzhou Jiuyuan, China | Inj.low mol.wt. heparin |
| APPLICATION RECEIVED FOR REGISTRATION TO IMPORT BULK DRUGS DURING YEAR 2007-08 | |||||||
| Month: January 2008 | |||||||
| S.No. | Date of Submission | Application Concerned (BD/FF) | Nature of Application (Fresh, Endorsement, Renewal) | RC No. & Date of Expiry | Name and address of Indian agent | Name and address of manufacturing site to be registered | Name of Drugs |
| 1 | 02/01/2008 | FF | Fresh | Esschem Pvt. Ltd., Mumbai | Fidia Farmaceutici SpA, Italy | 7 drugs | |
| 2 | 04/01/2008 | FF | Renewal | FF-324 31/03/2008 | J&J Ltd., Mumbai | Janssen Pharmaceutica Cilag, Italy | Lyrinel (Oxybutinin Chloride) extended release tablets 5 mg, 10 mg, 15 mg. |
| 3 | 10/01/2008 | BD | Endorsement | BD-49 31/12/2008 | Serdia Pharmaceuticals (India) Pvt. Ltd., Mumbai | Les Laboratories Sevier, France | Indapamide |
| 4 | 14/01/2008 | BD | Fresh | Nayyar Medicine Co., Delhi | Jintan Zhongxing Pharmaqceutical and Medical Co. Ltd., China | Clotrimazole | |
| 5 | 14/01/2008 | BD | Fresh | Nayyar Medicine Co., Delhi | Taizhou Candorly Sea Biochemical and Health Products Co. Ltd., China | Didanosine | |
| 6 | 16/1/2008 | BD | Endorsement | BD-551 30.06.2008 | Chr Hansen (India) Pvt. Ltd., Mumbai | Chr. Hansen A/S, Denmark | Probio-tec AB-Blend 1.5 Pre |
| 7 | 17/01/2008 | FF | Endorsement | FF-116 31/12/2008 | J&J Ltd., Mumbai | Janssen Pharmaceutica NV, Belgium | Durogesic (D-Trans Fentanyl transdermal patches 12mcg/hr) |
| 8 | 17/01/2008 | FF | Endorsement | FF-101 31/12/2008 | J&J Ltd., Mumbai | Cilag AG, Switzerland | Risperdal Consta (Risperidone prolonged release suspension 12.5 mg per vial |
| 9 | 18/1/2008 | BD | Fresh | Venus Remedies Limited, Chandigarh | Changhou Fangyuan Pharmaceuticals Co. Ltd., China | Etimicin Sulphate | |
| 10 | 18/1/2008 | FF | Fresh | Sandor Medicaids Pvt. Ltd., Hyderbad | Genzyme Biosurgery, Division of Genzyme Corporation, 76 New York Avenue, Framingham, MA 01701 USA | Seprafilm Adhsion Barrier | |
| 11 | 22/01/2008 | FF | Renewal | FF-252 31/03/2008 | Win Medicare Pvt. Ltd., Delhi | Orion Corporation, Finland | Estradiol 0.1% gel (DV gel) |
| 12 | 22/01/2008 | BD | Renewal | BD-499 | Nayyar Medicine Co., Delhi | Henan Kangrei,China | Norfloxacin |
| 13 | 22/01/2008 | BD | Fresh | Nayyar Medicine Co., Delhi | Suzhou Ausun Chemical Co. Ltd., China | Mephenemic Acid | |
| 14 | 22/01/2008 | BD | Fresh | Nayyar Medicine Co., Delhi | Changzhou Kangrui Chemical, China | Folic Acid | |
| 15 | 22/01/2008 | Fresh | Choksi Imaging Ltd., Pondicherry | Manufacturing: Biosensors Europe SA, Switzerland Premises: Nippon Kayaku Co. Ltd., Japan | Biolimus A-9 | ||
| 16 | 23/01/2008 | FF | Renewal | FF-321 31/03/2008 | Depuy Medical Pvt. Ltd., Mumbai | Codman & Shurtleff, Inc., USA | Duraform Dural Graft Implant |
| 17 | 24/1/2008 | BD | Fresh | Nicholas Piramal India Limited, Mumbai | Shangdong New Time Pharmaceuticals Co., Ltd., China | Sevoflurane | |
| 18 | 27/1/2008 | FF | Endorsement+D14 | FF-116 31/12/2008 | J&J Ltd., Mumbai | Janssen Pharmaceutica NV, Belgium | Durogesic (D-Trans Fentanyl transdermal patches 12mcg/hr) |
| 19 | 30/1/2008 | FF | Fresh | Fulford (I) Limited, Mumbai | Thierry Wermellinger, 2, rue Pasteur 14200 Herouville Saint Clair, France | Posaconazole Oral Suspension 40mg/ml | |
| 20 | 30/1/2008 | FF | Fresh | Fulford (I) Limited, Mumbai | Patheon Inc., Whitby Operations 111 Consumers Drive, Whitby Ontario, Canada L1N 5Z5 | Posaconazole Oral Suspension 40mg/ml | |
| 21 | 31/1/2008 | FF | Fresh | Novartis India Limited, Mumbai | Novartis Farma S.p.A., Via Provinciale Schito 131, I-80058 Torre Annunziata, Napoli, Italy | Valsartan + Hydrochlorothiazide | |
| 22 | 31/1/2008 | FF | Fresh | Saify Traders, Indore | Demtech Corp. 3530, NW 115 Ave, Miami, FI 33178, 306-597-5277 | Surgical Sutures | |
| 23 | 09/01/2008 | FF | Fresh | FF453,31/12/2007 | VHB LifeSciences, Mumbai | Polamine Werk, Germany | 5Drugs |
| 24 | 09/01/2008 | FF | Fresh | FF452,31/12/2007 | VHB LifeSciences, Mumbai | Korea United Pharma Inc., Korea | Dactinomycin Injection |
| 25 | 04/01/2008 | FF | Renewal | FF-324 31/03/2008 | J&J Ltd., Mumbai | Jansen Cilag S.PA,Italy | Lyrinel (Oxybutinin Chloride) |
| APPLICATION RECEIVED FOR REGISTRATION TO IMPORT BULK DRUGS DURING YEAR 2007-08 | ||||||
| Month - February 2008 | ||||||
| Date of Submission | Application Concerned (BD/FF) | Nature of Application (Fresh, Endorsement, Renewal) | RC No. & Date of Expiry | Name and address of Indian agent | Name and address of manufacturing site to be registered | Name of Drugs |
| 15/2/08 | BD | Fresh | G.C. Chemie Pharmie Ltd., 5/C Shree Laxmi Industrial Estate, New Link Road, Andheri (West), Mumbai-400 053 | Zhejiang Kangle Pharmaceutical Co. Ltd., Qujiang Road, Economic & Technologival Development Zone, Wenzhou, Zhejiang, China | Paracetamol EP/USP/IP | |
| 15/2/08 | BD | Fresh | Vita Pharma Agencies, 305, Arenja Corner, Plot No. 71, Sector 17, Vashi Navi, Mumbai-400 703 India | Zhejiang Starry Pharmaceutical Co. Ltd., Xainju Modern Ind. Centralization Zone Xianju, Zhejiang, China-317 300 | Iohexol | |
| 19/02/2008 | BD | Fresh | Renaissance Pharmaceuticals, Gala No.15, 2nd Floor, Bldg.NoanishCompound, Anjur Phata, Bhiwandi, District-Thane | Minsheng Group Shaoxing Pharmaceutical Co. Ltd., 315 Tanggong Rd.Paojiang industrialzone Shaoxing, China | Atropine Sulphate | |
| 20/2/08 | BD | Renewal | BD-59 | Esschem( Pvt.) Ltd., 19th Floor, Centre-1, World Trade Centre, Cuffe Parade, Mumbai- 400 005 | Fermic, S.A. de C.V., Refroma No. 873, Colonia San Nicolas Tolentino, 09850 Mexico, D.F. - Mexico | 1. Clavulanate Postassium + Avicel, 2. Clavulanate Postassium +Syloid, 3. Clavulanate Postassium Sterile + Amoxicillin Sodium Sterile |
| 22/02/2008 | BD | Endorsement | BD-696 | AV Chemicals, B1/201, Hyde Park, Off-Ghodbunder Road Near Tatwagyan Vidhyapeeth, Thane (West) 400610 | Archimica S.r.l., via vittar Pisani 16, 20124 Milano, Italy | |
| 27/2/08 | BD | Fresh | Great Fortune Chemie Pharmie Pvt. Ltd., 612, Kamdhenu Shopping Centre Building No.3, Swami Samath nagar, Andheri (West), Mumbai-400 053 | Shenzhen Haibin Pharmaceutical Co. Ltd., No. 2003, Shayan Road, Yantian District, Shenzhen, P.R.China | Meropenem Buffered Sterile | |
| 28/2/08 | BD | Endorsement | FF-206 | Rushi Corporation , B-102, Parsian Apartment, V.P. Road, Off, S.V.Road, Andheri (west), Mumbai-400 058, India | Hangzhou Jiuyuan Gene Engineering Co. Ltd., No 23, East of No. 8th Street, Hangzhou Economic and Technological Development Zone, Hangzhou, China | Enoxaparin Sodium in Bulk (i.e., API) |
| APPLICATION RECEIVED FOR REGISTRATION TO IMPORT FINISHED FORMULATIONS DURING YEAR 2007-08 | ||||||
| Month - February 2008 | ||||||
| Date of Submission | Application Concerned (BD/FF) | Nature of Application (Fresh, Endorsement, Renewal) | Registration Certificate No. | Name and address of Indian agent | Name and address of manufacturing site to be registered | Name of Drugs |
| 06/02/2008 | FF | Fresh | Blue Stream manufacturing Services Pvt. Ltd., Mumbai | Gojo Industries Inc., 3783 State Rd, Cuyahoga Falls, Ohio 44223, USA | 1. Micrell Antibacterial Foam Handwash, 2. Micrell Antibacterial Lotion Soap | |
| 02/02/2008 | FF | Renewal | FF-353 | Fulford (India) Ltd, " Eureka Towers", 8th Floor, Mindspace, Link road, Malad (West), Mumbai-400 064 | Orion Corporation, Orion Pharma, Turku Plant, Tengstrominkatu 8, P.O.Box 425, 20101 Turku, Finland | Temozolomide Capsule (Temodal) 5mg, 20mg, 100mg,250mg |
| 13/02/08 | FF | Renewal | FF-325 | Johnson & Johnson Ltd.,30, Forjett Street, Mumbai-400036 | Integra Life Sciences Corporation, 311 Enterprise Drive, Plainsboro, NJ 08536,USA | Chlorhexidine Gauze Dressing |
| 26/2/08 | FF | Fresh | Bristol Myers Squibb India Pvt. Ltd. Located at 1st Floor, 'A' Block, Shiv Sagar Estate, Dr. Annie Besant Road, Worli, Mumbai 400 018 | Baxter Oncology GmbH, Pharmaceutical Production, Kantstrasse 2, 33790 Halle/Westfalen, Germany | (1) Ixempra TM 15mg for injection (containing 1 vial of ixabepilone 15mg for injection and 1 vial of diluent 8ml), (2). Ixempra TM 45 mg for injection (containing 1 vial of ixabepilone 45mg for injection and 1 vial of diluent 23.5ml) | |
| 26/2/08 | FF | Renewal | FF-319 | Johnson & Johnson Ltd., 30, Forjett Street, Mumbai- 400 036 | Johnson & Johson International, c/o European Logistic Centre, Lenneke Marelaan, 6, BE-1932 St- Stevens-Woluwe, Belgium having factory premises at Ethicon GmbH, Robert-Koch-Str.1, D-22851 Norderstedt, Germany | (1).Ethisorb Dura Patch, (2). Ethisorb Burr-Hole Plug |
| 26/2/08 | FF | Fresh | Bristol Myers Squibb India Pvt. Ltd. Located at 1st Floor, 'A' Block, Shiv Sagar Estate, Dr. Annie Besant Road, Worli, Mumbai 400 018 | Baxter Oncology GmbH, Pharmaceutical Production, Kantstrasse 2, 33790 Halle/Westfalen, Germany | (1) Ixempra TM 15mg for injection (containing 1 vial of ixabepilone 15mg for injection and 1 vial of diluent 8ml), (2). Ixempra TM 45 mg for injection (containing 1 vial of ixabepilone 45mg for injection and 1 vial of diluent 23.5ml) | |
| 26/2/08 | FF | Renewal | FF-319 | Johnson & Johnson Ltd., 30, Forjett Street, Mumbai- 400 036 | Johnson & Johson International, c/o European Logistic Centre, Lenneke Marelaan, 6, BE-1932 St- Stevens-Woluwe, Belgium having factory premises at Ethicon GmbH, Robert-Koch-Str.1, D-22851 Norderstedt, Germany | (1).Ethisorb Dura Patch, (2). Ethisorb Burr-Hole Plug |
| APPLICATION RECEIVED FOR REGISTRATION TO IMPORT BULK DRUGS DURING YEAR 2007-08 | ||||||
| Month - March 2008 | ||||||
| Date of Submission | Application Concerned (BD/FF) | Nature of Application (Fresh, Endorsement, Renewal) | Registration Certificate No. & date of expiry | Name and address of Indian agent | Name and address of manufacturing site to be registered | Name of Drugs |
| 05/03/2008 | BD | Renewal | BD-556; 31/7/08 | DSM Nutritional products (I) Pvt. Ltd., Solitaire Corporate Park, VI Building, # 661/662, VI Floor, M Vasanji Marg, Andheri (E), Mumbai-400 093 | DSM Nutritional Products(UK) Ltd, Dalry, Ayrshire KA24 5JJ, Scotland, UK | 1. D-Panthenol USP/Ph. Eur., 2. Calcium D-Pantothenate USP/Ph. Eur., 3. Ascorbic Acid USP/Ph.Eur., 4. Sodium Ascorbate Crystalline USP/Ph. Eur. |
| 05/03/2008 | BD | Renewal | BD-545 ;30/6/2008 | DSM Nutritional products (I) Pvt. Ltd., Solitaire Corporate Park, VI Building, # 661/662, VI Floor, M Vasanji Marg, Andheri (E), Mumbai-400 093 | DMS Nutritional Products Inc, 206, Macks island Drive Belvidere, new Jersey 07823-1113, USA | 1. D-Alpha-Tocopheryl Acetate USP, 2. Dry Vitamin A Acetate 500 |
| 05/03/2008 | BD | Fresh | DPM Antibiotics, Ganesh Corporation, Office No. 19, Hissa No.4 & 5 Khandagale Estate, Purna Villae, Biwandi -421 302, Dist. Thane, Maharashtra, India | Taizhou Highsun Pharmaceutical Co. Ltd., Zhejiang National Chemical & Pharmaceutical Base of Linhai Zone, Linhai 317916, Zhejiang, China | Diacerein | |
| 05/03/2008 | BD | Renewal | BD-555 31/7/2008 | DSM Nutritional products (I) Pvt. Ltd., Solitaire Corporate Park, VI Building, # 661/662, VI Floor, M Vasanji Marg, Andheri (E), Mumbai-400 093 | DSM nutritional Products France SAS, 1, Boulevard D'Alsace, F-68128 Village-Neuf, France | 1. Beta Carotene 30% FS, 2. D-Biotin |
| 07/03/2008 | BD | Renewal | BD-546 30/6/08 | DSM Nutritional products (I) Pvt. Ltd., Solitaire Corporate Park, VI Building, # 661/662, VI Floor, M Vasanji Marg, Andheri (E), Mumbai-400 093 | DMS Nutritional Products Gmbh, D-79639, Grenzach-Whylen, Germany | 1. Pyridoxine Hydrochloride BP/USP/IP, 2. Thiamine Mononitrate BP/USP/IP, 3. Thiamine Hydrochloride BP/USP/IP, 4. Riboflavin Universal USP/Ph.Eur. |
| 07/03/2008 | BD | Renewal | BD-558 31/7/08 | DSM Nutritional products (I) Pvt. Ltd., Solitaire Corporate Park, VI Building, #661/662, VI Floor, M Vasanji Marg, Andheri (E), Mumbai-400 093 | DSM Nutritional products Ltd, Branch Site Sisseln, Hauptstrasse 4, Ch-4334 Sisselin, Switzerland | 1. Dl-Alpha-Tocopheryl Acetate, 2.Vit. A palmitate 1.7 miu/g (Toco), 3. Vit. D3 Crystalline, 4. |
| 07/03/2008 | BD | Fresh | Nayyar medicine Co., A-29, 3rd Floor, Sanjay Nagar, mangolpur Kalan, Delhi-110 085 | Chongqing Chunrui Medicine Chemical Co. Ltd No.44, Luoxi Road, Luoqi Town, Yubei District, Chongqing, China | Chloramphwnicol BP | |
| 07/03/2008 | BD | Endorsement | BD-685 ; 31/8/10 | Nayyar medicine Co., A-29, 3rd Floor, Sanjay Nagar, mangolpur Kalan, Delhi-110 085 | Zhejiang Supor Pharmaceutical Co. ltd. Yuedong Road, Paojiang Industrial zone, Shaoxing, Zhejiang 312071, PP.R.China | Tinidazole USP/BP/EP |
| 13/3/08 | BD | Renewal | BD-27 ; 31/12/08 | Esschem( Pvt.) Ltd., 19th Floor, Centre-1, World Trade Centre, Cuffe Parade, Mumbai- 400 005 | Ercros industrial, S.A., Paseo del Deleite s/n, 28300 Aranjuez (Madrid), Spain | 1. Fusidic Acid BP/EP, 2. Sodium Fusidate BP/EP |
| 17/3/08 | BD | Renewal | BD-53 ; 31/12/08 | Fulford (India) ltd, Eureka Towers, B-Wing, 8th Floor, Mindspace, Link Road, Malad (West), Mumbia-400 064 | Schering Plough (Avondale ) Company, Rathdrum, Co. Wicklow, Ireland | Dexchlorpheniramine Maleate |
| 20/3/08 | BD | Endorsement | BD-688 ; 31/8/10 | Anantco Enterprises Pvt. Ltd., 194, Arcind Chambers, Gauri Studio Compound, Western Express Highway, Andheri (E), Mumbai-400 069 | Shijiazhuang Pharma Group Hebei Zhongrun Pharmaceutical Co. Ltd, 47, fengshou Road, Shijiazhuang City, Hebei Provice China | 1. Amoxicillin Rrihydate, 2. Ampicillin Trihydate |
| 24/3/08 | BD | Renewal | BD-52; 31/12/08 | Fulford (India) ltd, Eureka Towers, B-Wing, 8th Floor, Mindspace, Link Road, Malad (West), Mumbia-400 064 | Schering-Plough Ltd, 50, Tuas West Drive, Singapore 638408, Republic of Singapore | 1. Mometasone Furoate, 2. Betamethasone Dipropionate |
| 24/3/08 | BD | Renewal | BD-54 | Fulford (India) ltd, Eureka Towers, B-Wing, 8th Floor, Mindspace, Link Road, Malad (West), Mumbia-400 064 | Fujian Fukang Pharmaceutical Co. Ltd. No.138, Xiangban Road, Taijiang District, Fuzhou, China 350 002 | 1. Gentamicin Sulphate , 2. Sisomicin Sulphatte |
| 24/3/08 | BD | Fresh | Chephis Corporation, 1st Floor, Sunbeam Chambers, 7-C, New Marine Lines, Mumbai 400 020 | Shenzhen Gosun Pharmaceutical Co. Ltd., No.2, Kaifeng Road, Shangmeilin, Shenzhen, China P.R. 518 049 | Cefotaxime Sodium Sterile | |
| 24/3/08 | BD | Renewal | BD-35 ; 31/12/08 | Rushi Corporation , B-102, Parsian Apartment, V.P. Road, Off, S.V.Road, Andheri (west), Mumbai-400 058, India | Crystal Pharma S.A., Parque Tecnologico- Parcela 105, 47151 Boecillo (Valladolid) Spain | 1. Beclomethasone Dipropionate BP/USP/Eur.Ph, 2. Budesonide BP/USP/Eur. Ph., 3. Hydrocoritisone Hemisuccinatte BP/USP/Eur.Ph., 4. Hydrocortisone Butyrate, BP/USP/ Eur. Ph., 5. Hydrocortisone Sodium Succinate Buffered 3%, Sterile, USP, 6. Methylprednisloln |
| 24/3/08 | BD | Fresh | Ethachem 103, Marine Chambers,11, New Marine Lines, Mumbai-400 020 | Inalco S.p.A. , Via Calabiana 18, 20139, Milano,Italy having factory premises at Societa Chimica Mugello (S.C.M), Via E Matteri 26, 50039 Vicchio, firenze, Italy | Lactulose Soulution USP | |
| 26/3/08 | BD | Fresh | Orchid healthcare, (A Divison of Orchid Chemicals & Pharmaceuticals Ltd.,) Orchid Towers, 313, Valluvarkottam High Road, Nungambakkam, Chennai-600 034, Tamilnadu, India | Hikma Italia SpA, Viale Certosa No.10-27100 Pavia, Italy | Somatostatin | |
| 26/3/08 | BD | Renewal | BD-69 ; 31/12/08 | Supreme Combine, Ratilal Mansion, Dr. Parekh Path, Prathana Samaj, Mumbai-400 004 | Boehringer Ingelheim Pharma GmbH & Co. KG, Binger Strasse 173, 55216 Ingelheim an Rhein, Germany | Phenylephrine Hel,2. Homatropine Hydrobromide, 3. Digoxin |
| 31/3/08 | BD | Renewal | BD-72 ; 31/12/08 | Aventis Pharma Ltd., Rajlaxmi Comm Complex, Bldg- H, Unit 1-10, Unit 13,14,17A, 17B, 18 to 22 Durgesh Park, Bhiwandi, India | Sanofi Chimie, Centre de Production de Romainville, 143, avenue Gaston Roussel 93231, Romainville, Cedex France | Framycetin Sulphate |
| 31/3/08 | BD | Renewal | BD-115 ; 31/12/08 | Johnson & Johnson Ltd.,30, Forjett Street, Mumbai-400036, India | Janssen Pharmaceutica, Lammerdries 55, B-2250 Olen, Belguim | Itraconazole Pallets (Bulk Drug) |
| 31/3/08 | BD | Renewal | BD-114 ; 31/12/08 | Johnson & Johnson Ltd.,30, Forjett Street, Mumbai-400036, India | Janssen Pharmaceutica, Janssen Pharmaceuticalaan 3, B-2440 Geel, Belgium | 1. Cinnarizine, 2. Domperidone, 3. Domperidone maleate, 4. Flunarizine hydrochloride, 5. Risperidone |
| 31/3/08 | BD | Renewal | BD-429 ; 30/6/07 | Esschem( Pvt.) Ltd., 19th Floor, Centre-1, World Trade Centre, Cuffe Parade, Mumbai- 400 005 | Icrom S.p.A., Via Primo Maggio, 36-20049 Concorezzo (MI), Italy | Sulpiride |
| APPLICATION RECEIVED FOR REGISTRATION TO IMPORT FINISHED FORMULATION DURING YEAR 2007-08 | ||||||||
| Month - March 2008 | ||||||||
| Date of Submission | Application Concerned (BD/FF) | Nature of Application (Fresh, Endorsement, Renewal) | Registration Certificate No. & date of expiry | Name and address of Indian agent | Name and address of manufacturing site to be registered | Name of Drugs | ||
| 07/03/2008 | FF | Fresh | Cipla Ltd, 289, Bellasis Road, Mumabi Central, Mumbai -400 008, maharastra, India | Tokuhon Corporation, 2-28-8, Shiba, Minato-ku, Tokyo 105-0014, Japan having factory premises Tokuhon Corportation, 1010, Aza-Yamazki, Miyashiro-machi, Minamisitama-gum, Saitama, Japan | ||||
| 10/03/2008 | FF | Renewal | FF-41;31/12/08 | Novartis India Ltd., Sandoz House Shivsagar Estate, Dr. Annie Besant Road, Worli, Mumbai -400018 | Norvartis Farmaceutica SA., Ronda de Santa Maria 158, 08210 Barcelona, Spain | (1). Exelon (rivastogmine) capsules 1.5mg/3.0 mg/4.5 mg/6.0mg, (2). Diovan (valsartan) film coated tablets 40 mg/80mg/160mg | ||
| 17/3/08 | FF | Renewal | FF-27; 31/12/08 | Fulford (India) ltd, Eureka Towers, B-Wing, 8th Floor, Mindspace, Link Road, Malad (West), Mumbia-400 064 | Schering-Plough Products, LLC Pridco Industrial Park, Las piedras, puerto Rico 00771-2011 | Rabavirin Capsules 200mg | ||
| 18/3/08 | FF | Renewal | FF-352; 14/12/08 | Modi Mundi Pharma Pvt. Ltd. 1400 Modi Tower, 98, Nehru Place, New Delhi-19 | Leo Pharmaceutical Products Ltd., A/S, Industriparken 55, Denmark-2750, Ballerup, Denmark | Daivonex Scalp Solution | ||
| 19/3/08 | FF | Renewal | FF-71; 31/12/08 | Fulford (India) ltd, Eureka Towers, B-Wing, 8th Floor, Mindspace, Link Road, Malad (West), Mumbia-400 064 | Schering -Plough (Brinny) Company, Innishannon, County Cork, Ireland | (1). Pegylated Interferon Alfa-2b 50mcg, 80mcg,120mcg,150mcg, (2). Interferon Alfa-2b Multidose Pen 18 miu, 30miu, 60miu | ||
| 20/3/08 | FF | Endorsement | FF-116 ; 31/12/08 | Johnson & Johnson Ltd., 30, Forjett Street, Mumbai- 400 036, India | Janssen Pharmaceutica NV, Turnhoutseweg 30, B-2340 Beerse Belgium | Dacogen (Decitabin 50mg/vial injection) | ||
| 24/3/08 | FF | Renewal | FF-29 ; 31/12/08 | Fulford (India) ltd, Eureka Towers, B-Wing, 8th Floor, Mindspace, Link Road, Malad (West), Mumbia-400 064 | Medimmune Pharma B.V. Lagelandseweg 78, 6545 CG Nijmegen, The Netherlands | Amifostine Injection (Ethyol) 375mg/500mg | ||
| 24/3/08 | FF | Renewal | FF-72 | Fulford (India) ltd, Eureka Towers, B-Wing, 8th Floor, Mindspace, Link Road, Malad (West), Mumbia-400 064 | Centorcor B.V., Einsteinweg 101, P.O.Box 251, 2300 A G Leiden, The Netherlands | Infliximab 100mg (Remicade) | ||
| 29/3/08 | FF | Fresh | Wyeth Limited, RBC Mahindra Towers, 4th Floor, 'A' Wing, Dr. G.M Bhosale Road, Worli, Mumbai-400018 | Wyeth Parenterals, Division of Wyeth Holdings Corporation, 65th Infantry Avenue, Kilometer 9.7, Carolina, Puerto Rico 00987 | Tigecycline for injection (50 mg/vial), Tygacil* 50mg | |||
| 31/3/08 | FF | Renewal | FF-81 ; 31/12/08 | Aventis Pharma Ltd., Rajlaxmi Comm Complex, Bldg- H, Unit 1-10, Unit 13,14,17A, 17B, 18 to 22 Durgesh park, Bhiwandi | Patheon UK Ltd., Kinfisher Drive, Covingham, Swindon, Wiltshir, SN3 5BZ, United Kingdom | 1. Cefpirome Injection 0.25gm and 1gm (Cefrom), 2. Sofratulle {Framycetin Sulphate 1% w/w (10mg/g)} | ||
| 31/3/08 | FF | Renewal | FF-85 ; 31/12/08 | Aventis Pharma Ltd., Rajlaxmi Comm Complex, Bldg- H, Unit 1-10, Unit 13,14,17A, 17B, 18 to 22 Durgesh park, Bhiwandi | Aventis Pharma, Dagenham, Rainham Road South, Dagenham, Essex RM 10 7XS, United Kingdom | Docetaxel (Taxotere) Injection Concentrate 20 mg/0.5ml and 80 mg/2ml | ||
| 31/3/08 | FF | Renewal | FF-21 ; 31/12/08 | Galderma India Pvt. Ltd., 23 Steelmade Industrial Estate, 2nd Floor, Marol Village, Andheri (E), Mumbai -400 059 | Galderma International of Tour Europlaza, La Defense 4, 20 avenue Andre Prothin., 92927 la Defense Cedex, France having factory premises at Laboratoies Galderma Zone Industrielle- Montdesir, 74540 Alby-sur-Cheran, France | 1. Adapalene gel (0.1%), 2. Calcitriol ointment 3 ug/gm (3 micrograms per gram), 3. Amorolfine Nail Lacquer (5%) and Cream (0.25%) | ||
| 31/3/08 | FF | Renewal | FF-116 ; 31/12/08 | Johnson & Johnson Ltd.,30, Forjett Street, Mumbai-400036, India | Janssen Pharmaceutica NV, Turnhoutseweg 30, B-2340 Beerse Belgium | 1. Bortezomib for injection (each single dose vial contains bortezomib 3.5mg), 2. Durogesic (D-Trans Fentanyl transdermal patches 25mcg/hr, 50mcg/hr, 75mcg/hr and 100mcg/hr) | ||
| 31/3/08 | FF | Fresh | RFCL Ltd., A-3, Okhla Industrial Area, Phase-1, New Delhi | Alpharma Inc 400 state Street, Chicago Heights IL 60411 USA | BMD Soluble 50% | |||
| 31/3/08 | FF | Renewal | FF-86 ; 31/12/08 | Wyeth Limited, RBC Mahindra Towers, 4th Floor, 'A' Wing, Dr. G.M Bhosale Road, P.O Box 6585, Worli, Mumbai-400018 | John Wyeth & Brother Ltd, New Lane, Havant, Hampshire, P09 2NG, UK | Entanercept 25mg solution for injection in prefilled syringe (Enbrel * 25mg) | ||
| 31/3/08 | FF | Renewal | FF-86 ; 31/12/08 | Wyeth Limited, RBC Mahindra Towers, 4th Floor, 'A' Wing, Dr. G.M Bhosale Road, P.O Box 6585, Worli, Mumbai-400018 | John Wyeth & Brother Ltd, New Lane, Havant, Hampshire, P09 2NG, UK | Tigecycline 50mg powder for injection (Tygacil* 50mg) | ||
| 31/3/08 | FF | Renewal | FF-67 ; 31/12/08 | Wyeth Limited, RBC Mahindra Towers, 4th Floor, 'A' Wing, Dr. G.M Bhosale Road, P.O Box 6585, Worli, Mumbai-400018 | WyethAyerst Lederle Inc. ("Wali"), 65th Infantary Km. 9.7, Carolina, Puerto Rico 00987 | Piperacillin and Tazobactam for Injection 4.5 gms cials (Zosyn*4.5gms) | ||
| 31/3/08 | FF | Renewal | FF-86 ; 31/12/08 | Wyeth Limited, RBC Mahindra Towers, 4th Floor, 'A' Wing, Dr. G.M Bhosale Road, P.O Box 6585, Worli, Mumbai-400018 | John Wyeth & Brother Ltd, New Lane, Havant, Hampshire, P09 2NG, UK | Etanercept 50mg solution for injection in prefilled syringe (Enbrel* 50mg) | ||
| 31/3/08 | FF | Renewal | FF-86; 31/12/08 | Wyeth Limited, RBC Mahindra Towers, 4th Floor, 'A' Wing, Dr. G.M Bhosale Road, P.O Box 6585, Worli, Mumbai-400018 | John Wyeth & Brother Ltd, New Lane, Havant, Hampshire, P09 2NG, UK | Etanercept 25mg powder of rinjection in vial (Enbrel*25mg) | ||
| 31/3/08 | FF | Renewal | FF-101; 31/12/08 | Johnson & Johnson Ltd.,30, Forjett Street, Mumbai-400036, India | Cilag AG, Hochstrasse 201, CH 8205 Schaffhausen, Switzerland | 1.Topirmate Tablets 25 mg/50mg/100mg, 2. Topiramate sprinkle capsules (Each sprinkle capsule contains topiramate 15mg/25mg/50mg), 3. Recombinant human erythropoietin 1000IU/2000IU/3000IU/4000IU/6000IU/ 800 IU/ 10000IU //40000IU in prefilled syringes, 4. R | ||
| 31/3/08 | FF | Renewal | FF-79 ; 31/12/08 | B. Braun Medical (India) Pvt. Ltd., 5th Floor East Quadrant, The IL & FS Financial Centre, Bandra Kurla Complex, Bandra (E), Mumbai-400 051 | B.Braun Melsungen AG, Carl-Braun-Strassw 1, D-34212 Melsungen, Germany | 1. Aminoplasmal 10%, 2.Aminoplasmal Hepa 10% ,3.Aminoplasmal 5% E ,4.Aminoplasmal 10%E, 5. Lipofundin MCT/LCT 10%, 6.Lipofundin MCT/LCT 20%, 7.Lipofundin N 10%, 8.Lipofundin N 10%, 9. Nutriflex Lipid Per, 10.Nutriflex Lipid Plus, 11.Nutriflex Lipid Specia | ||
| 31/3/08 | FF | Renewal | FF-78 ; 31/12/08 | B. Braun Medical (India) Pvt. Ltd., 5th Floor East Quadrant, The IL & FS Financial Centre, Bandra Kurla Complex, Bandra (E), Mumbai-400 051 | B. Braun Medical Industries SDN. BHD., Bayan Lepas Free Inustrial Zone, P. O. Box. 880 10810 Penang, Malaysia | 1. 5% w/v Glucose intravenous Infusion BP in 100ml, 500ml and 1000ml Polyethylene Container, 2. 0.9% w/v Sodium Chloride Intravenous Infusion BP in 100ml, 500ml and 1000ml Polyethylene Container, 3. 0.9% w/v Sodium Chloride and 5% w/v Glucose Intravenous | ||
| 07/03/2008 | FF | Fresh | Cipla Ltd, 289, Bellasis Road, Mumabi Central, Mumbai -400 008, maharastra, India | Tokuhon Corporation, 2-28-8, Shiba, Minato-ku, Tokyo 105-0014, Japan having factory premises Tokuhon Corportation, 1010, Aza-Yamazki, Miyashiro-machi, Minamisitama-gum, Saitama, Japan |
| APPLICATION RECEIVED FOR REGISTRATION TO IMPORT DRUGS DURING YEAR 2007-08 | |||||||
| MONTH OF APRIL 2008 | |||||||
| S.No. | Date of Submission | Application Concerned (BD/FF) | Nature of Application (Fresh, Endorsement, Renewal) | RC No. & Date of Expiry | Name and address of Indian agent | Name and address of manufacturing site to be registered | Name of Drugs |
| 1 | 02/04/2008 | FF | Renewal | FF-1 31/12/2008 | Roche Scientific Co. (I) pvt. Ltd., B/2, Amarchand Mansion, 1st Floor, Madam Cama Road, Mumbai-400039 | M/s Sanofi Winthrop Industrie, 1 Rue de la Vierge, Ambares et Lagrave, 33565, Carbon blanc, Cedex, France | 1. Plavix 75 mg (Clopidogrel hydrogen sulphate equivalent to 75 mg Clopidogrel) 2. Cordarone Injection (Amiodarone Hydrochloride Injection 150 mg / 3ml) 3. Aprovel Tablets (Irbesartan tablets 75 mg / 150 mg / 300mg) 4. Co- Aprovel Tablets (Irbesartan / Hydrochlorthiazide 150 mg + 12.5 mg / 300mg + 12.5 mg and 300 mg + 25 mg tablets) |
| 2 | 02/04/2008 | FF | Renewal | FF-43 31/12/2008 | Roche Scientific Co. (I) pvt. Ltd., 2nd Floor, 165,Dr. Annie Besant Road, Worli, Mumbai-400018 | R. P. Scherer GmbH & Co. KG, Gammelsbacher Strasse 2, D-69412, Bberbach/Baden, Germany | 1. Isotretinoin [ROACCUTANE] capsules 910 mg and 20 mg), 2. Calcitriol [ROCALTROL] capsules (0.25 µg and 0.5 µg), 3. All Transretinoic Acid (Tretinoin) [VESANOID] capsules (10 mg) |
| 3 | 03/04/2008 | FF | Renewal | FF-107 31/12/2008 | Sanofi-Synthelabo (India) Limited, Rajlakshmi Commercial Complex, Building No. H, Unit No. 15, 16A, Opp. Durgesh Park, Kalher Village, Taluka Bhiwandi, District Thane | F. Hoffmann-la rocheLtd., Switzerland having factory premises at Roche Diagnostics GmbH, Sandhofer Strasse 116, D-68305 Mannheim, Germany | 1. Ibandronic acid [BONDRONAT] - Vials (6 mg/6ml), 2. Epoetin beta [NEORECORMON] - Pre-filled syringes (1000 IU, 2000 IU, 3000 IU, 4000 IU, 5000 IU, 10,000 IU, 30,000 IU), 3. Methoxy polyethylene glycol-epoetin beta solution for injection [MIRCERA] in pre-filled syringes (each pre-filled syringe containing 50 µg, 75µg, 100 µg, 150 µg, 200 µg, 250 µg, of Methoxy polyethylene glycol-epoetin beta in 0.3 ml or 800 µg of Methoxy polyethylene glycol-epoetin beta in 0.6 ml), 4. Transtuzumab [HERCEPTIN] - Vials (150 mg/vial), 5. Peginterferon alfa-2a [PEGASYS] - pre-filled Syringes (180 mcg and 135 mcg) |
| 4 | 03/04/2008 | FF | Renewal | FF-6 31/12/2008 | Roche Scientific Company (India)Pvt. Ltd. B/2, Amarchand Mansion, 1st Floor, Madam Cama Road, Mumbai 400039 | NINGBO DOUBLE SUN FARMACEUTICAL Co., LTD. 5 # NAN HAI RD., DAGANG INDUSTRIAL DIST., BEILUN NINGBO, ZHEJIANG, CHINA 314800 | GLICLAZIDE BP |
| 5 | 03/04/2008 | FF | Renewal | FF-3 31/12/2008 | Roche Scientific Company (India)Pvt. Ltd. B/2, Amarchand Mansion, 1st Floor, Madam Cama Road, Mumbai 400039 | BAXTER HEALTHCARE PTE. LTD., 2 WOODLANDS, INDUSTRIAL PARK, D, SINGAPORE | 1. Dianeal PD-2 Peritoneal dialysis Solution with 1.5% Dextrose, 2. Dianeal PD-2 Peritoneal Dialysis Solution with 2.5% Dextrose, 3. Dianeal PD-2 Peritoneal Dialysis Solution with 4.25% Dextrose, 4. Dianeal PD-2 Peritoneal Dialysis Solution ultrabag, with 1.5% Dextrose, 5. Dianeal PD-2 Peritoneal Dialysis Solution ultrabag, with 2.5% Dextrose, 6. Dianeal PD-2 Peritoneal Dialysis Solution ultrabag, with 4.25% Dextrose, 7. Low Calcium Peritoneal Dialysis Solution with 1.5% Dextrose, 8. Low Calcium Peritoneal Dialysis Solution with 2.5% Dextrose, 9. Low Calcium Peritoneal Dialysis Solution with 4.25% Dextrose, 10. Low Calcium Peritoneal Dialysis Solution ultrabag with 1.5% Dextrose, 11. Low Calcium Peritoneal Dialysis Solution ultrabag with 2.5% Dextrose, 12. Low Calcium Peritoneal Dialysis Solution ultrabag with 4.25% Dextrose, 13. Extraneal Peritoneal Dialysis Solution with Icodextrin 7.5% |
| 6 | 03/04/2008 | BD | Fresh | Nayyar medicine Co., A-29, 3rd Floor, Sanjay Nagar, mangolpur Kalan, Delhi-110 085 | AVENTIS PHARMA S.A., FRANCE having factory premises at AVENTIS PRINCIPES ACTIFS PHARMACEUTIQUES, USINE DE PRODUCTION, CHIMIQUE, 63480 VERTOLAVE, FRANCE) | 1. Spironolectone U.S.P./E.P., 2. Dexamethasone Sodium metasulfobenzoate, 3. Dexamethasone Acetate U.S.P./ E.P., 4. Clobazam E.P., 5. Hydrocortisone Acetate U.S.P./E.P. | |
| 7 | 03/04/2008 | FF | Renewal | FF-122 31/12/2008 | BAXTER (INDIA) PRIVATE LIMITED, ENKAY TOWERS, 5th FLOOR, UDYOG VIHAR, PHASE V, GURGAON, HARYANA-122106 | F. Hoffmann-la roche Ltd., Grenzacherstrasse 124, CH-4070 Basel, Switzerland having factory premises at Hoffman La Roche Ltd., Grenzacherstrasse 124, CH-4070 Basel, Switzerland | 1. Filgrastim Pre-filled Syringes {1 pre-filled syringe of Neupogen of 0.5 ml contains 30 MU (=300 µg) of filgrastim} and Vials {1 vial of Neopogen of 1.0 ml injection solution contains 30 MU (= 300 µg) of filgrastim} [NEUPOGEN], 2. Rituximab Vials 500mg and 100 mg {1 vial of 100mg contains 100 mg/ 10 ml and 1 vial of 500 mg contains s00 mg/50 ml} [MABTHERA], 3. Ganciclovir sodium 500mg vials {1 Vial contains dry substance equivalent to 500 mg ganciclovir and approximately 46 mg (2 m Eq) sodium} [CYMEVENE], 4. Inerferon alfa-2a Pre-filled syringes {1 pre-filled syringe of Roferon-A (for single-dose, s.c. injection) contains 3 or 4.5 MIU interferon alfa-2a in 0.5 ml.} [ROFERON - A], 5. Levodopa 100 mg/200mg+Benserazide 25 mg/50 mg tablets [MADOPAR], 6. Pegnterferon alfa-2a Pre-filled Syringes {each single use syringe contains 0.5 ml with 180 mcg peginterferon alfa-2a} and Vials {each vial contains 1.0 ml with 180 mcg of peginterferon alfa-2a} [PEGASYS], 7. Saquinavir 200 mg hard gelatin capsules {each capsule containing 200 mg saquinavir equivalent} [INVIRASE], 8. Ibandronic acid 150 mg film-coated teblets {One 150 mg film-coated teblet contains 168.75 mg of ibandronic acid, monosodium salt, monohydrate equivalent to 150 mg of ibandronic acid} [BONVIVA®] and Ibandronic acid 50 mg film-coated teblets {one 50 mg film-coated teblet contains 56.25 mg of ibandronic acid, monosodium salt, monohydrate corresponding to 50 mg ibandronic acid} [BONDRONAT®], 9. Oseltamivir capsules (75 mg) {containing 98.5 mg oseltamivir phosphate equivalent to 75 mg of oseltamivir} [TAMIFLU®] ad Oseltamivir powder for oral suspension (which when constituted with water to a concentration of 1.2% contains 12 mg/mL oseltamivir) [TAMIFLU®], 10. Pegfilgrastim pre-filled syringes {containing 6 mg of pegfilgrastim in 0.6 ml (10 mg/ml) solution for injection} [NEULASTIM®], 11. Methoxy polyethylene glycol-epoetin beta solution for injection supplied as a sterile, ready to use liquid in single dose vials (each vial containing 50 µg, 100 µg, 200 µg, 300 µg, 400 µg, 600 µg or 1000 µg of Methoxy polyethylene glycol-epoetin beta)[MIRCERA], 12. Bevacizumab 100 mg or 400 mg vials {each 100 mg vial contains 4 ml of bevacizumab (25 mg/ml) and each 400 mg vial contains 16 ml of bevacizumab (25mg/ml)} [AVASTIN], 13. Trastuzumab 150 mg single dose vials {containing powder for concerntrate for solution for infusion} [HERCEPTIN], 14. Epoetin beta Pre-filled Syringes {containing 2000 IU, 4000IU, 5000 IU} [NEORECORMON®], 15. Erlotinib Hydrochloride tablets (25 mg, 100 mg, & 150 mg) {One film-coated teblet of each strength contains erlotinib hydrochloride, corresponding to 25 mg, 100 mg and 150 mg of erlotinib} [TARCEVA], 16. Daclizumab vials (Vials containing 25 mg of daclizumab in 5 ml of solution for infusion (5 mg/ml) [ZENAPAX®] |
| 8 | 25/10/07 (File was traced in the month of March) | FF | Renewal | FF-341 | Novartis India Limited, Sandoz House Shivsagar Estate, Dr. Annie Besant Road, Worli, Mumbai - 400018 | Novartis Pharma AG, Switzerland having premises factory at Sandoz GMBH, Schaftenau Plant, Biochemistries 10, 6336 Langkampeen, Austria | 1. Sandostatin LAR (octreotide long-acting release injection) vial with needles and prefilled syringe containing solvent for parenteral use, strength - 10 mg/20mg/30 mg |
| 9 | 03/04/2008 | BD | Renewal | BD-86 31/12/2008 | AVENTIS PHARMA LIMITED, AVENTIS HOUSE, 54/A, SIR MATHURADA VASANJI ROAD, ANDHERI (E), MUMBAI-400093 | Novartis Pharma Stein AG, Schaffhauserstrasse, 4332 Stein, Switzerland | 1. Basiliximab injection /i.v. infusion (Simulect) vial with ampoule of water for injction-20 mg, 2. Cyclosporin injection (Desferal) vial-50 mg/ml, 3. Desferrioxamine injection (Desferal) vial- 500mg, 4. Everolimus (Certican) teblets-0.25 mg/ 0.5 mg/ 0.75 mg/ 1.0 mg, 5. Glyceryl trinirtrate transdermal patches containing nitroglycerin (Nitroderm TTS 5)-25 mg, 6. Imatinib Mesilate (Glivec) tablets-100 mg/400 mg, 7. Letrozole (Femara) tablet-2.5 mg, 8. Mycophenolatr sodium (Myfortic) tablets-180 mg/360 mg, 9. Octreotide injection (Sandostatin) ampoules-0.05 mg/ml;0.10 mg/ml, 10. Valsartan (Diovan) tablets-40 mg/ 80 mg/160 mg, 11. Valsartan + Hydrochlorothiazide (Co-Diovan) tablets-80 mg+12.5 mg/160 mg+12.5 mg/160 mg+25mg, 12. Zoledronic acid (Zometa) concentrate for soluction for infusion vial-4 mg/5 ml, 13. Omalizumab injection (Xolair) powder vial with solvent ampoule for solution for injection-75 mg/ 150 mg. |
| 10 | 03/04/2008 | FF | Renewal | FF-445 31/12/2008 | UCB India Private Limited, 504 Peninsula Towers, G.K. Marg, Lower Parel, Mumbai-400013 | UCB Pharma S.A., Chemin du Foriest, B - 1420 Braine - I' Alleud, Belgium | Keppra® {Levetiracetam} 250 mg/500 mg/ 1000 mg Tablets |
| 11 | 03/04/2008 | FF | Renewal | FF-68(End.1 & End.2) 31/12/2008 | Wyeth Limited, RBC Mahindra Towers, 4th Floor, 'A' Wing, Dr. G.M Bhosale Road, P.O Box 6585, Worli, Mumbai-400018 | Baxter Healthcare Ltd., Caxton Way, Thetford, Norfolk, IP24 3SE, Great Britain | 1. Clinimix N17G35E, Solution for infusion 10% amino acids WITH electrolystes and Glucose 35% WITH Calcium, 2. Clinimix N17G35, Solution for infusion 10% amino acids WITH electrolytes and Glucose 35% WITHOUT Calcium |
| 12 | 03/04/2008 | FF | Renewal | FF-351 31/11/2008 | Wyeth Limited, RBC Mahindra Towers, 4th Floor, 'A' Wing, Dr. G.M Bhosale Road, P.O Box 6585, Worli, Mumbai-400018 | Egidio Folli 50, 20134 Milan (Italy)having premises factory at Bracco Imaging BV, 31, Route de la Galaise, 1228 Plan-les-Ouates/Geneva, Switzerland | Sulphure Hexafluoride for injection |
| 13 | 04/04/2008 | FF | Renewal | FF-52 31/12/2008 | Novartis India Limited, Sandoz House Shivsagar Estate, Dr. Annie Besant Road, Worli, Mumbai - 400018 | Dongying Tiandong Biochemical Industry Co., Ltd. No. 1236, Nan-er Road, Dongying, Shandong Province, China | Enoxaparin Sodium EP 5.3 |
| 14 | 04/04/2008 | FF | Fresh | Imagine product india Pvt. Ltd., 1 silver stone, 294 Linking Road, Khar (W), Mumbai 400052 | |||
| 15 | 04/04/2008 | BD | Renewal | BD-97 31/12/2008 | GlaxoSmithKline Pharmaceuticals Limited, Dr. Annie Besant Road, Mumbai-400030 | Kyowa Hakko Kogyo Co. Ltd., Fuji Plant, 1188 Shimotogari, Nagaizumi-CHO, Sunto-Gun, Shizuoka Japan | 1. Leunase (L-Asparaginase) Injection 5,000KU, 2.Leunase (L-Asparaginase) Injection 10,000KU |
| 16 | 04/04/2008 | BD | Renewal | BD-101 31/12/2008 | Chemet, 214, Hans Bhawan, Wing No.1, Bahadurshah Zafar Mrg, New Delhi-110002 | Edmond Pharma S.R.L. Via Dei Giovi, 131 20037 Paderno Dugnano(MI), Italy | 1. Erdosteine(INN), 2. Indapamide(INN), 3. Stanozolol(INN) , 4. Tenoxicam(INN) |
| 17 | 04/04/2008 | FF | Renewal | FF-357 31/12/2008 | Bristol Myers Squibb India Pvt. Ltd. Located at 1st Floor, 'A' Wing, Shiv Sagar Estate, Dr. Annie Besant Road, Worli, Mumbai 400 018 | Kyowa Hakko Kogyo Co. Ltd., Fuji Plant, 1188 Shimotogari, Nagaizumi-CHO, Sunto-Gun, Shizuoka Japan | Mitomycin-C Bulk Powder Sterile with sodium Chlorid Sterile |
| 18 | 07/04/2008 | BD | Renewal | BD-526 30/04/2008 | APC Pharmaceuticals & Chemicals, 43, Vikas Centre, 106, S. V. Road, Santacruz (W), Mumbai-400054 | DSM Anti-Infectives Chemferm S.A., C/Ripolles 2, Poligono Industrial Urvasa, 08130, Santa Perpetua De Mogoda, Barcelona, Spain | Cephalexin Monohydrate BP/USP/Ph. Eur. |
| 19 | 08/04/2008 | FF | Renewal | FF-96 | Baxter (India) Pvt. Ltd, Enkay Towers, 5th Floor, Udyog Vihar, Phase V, Gurgaon, Haryana-122106 | DSM Anti-Infectives Sweden AB, Mariefredsvagen 35, S-64541, Strangnas, Sweden | Mixture of Potassium Clavulanate with Microcrystalline Cellulose in the Ratio 1:2, Mixture of Potassium Clavulanate with Silicondioxide in the Ratio 1:1 |
| 20 | 08/04/2008 | BD | Renewal | BD-543 30/06/2008 | APC Pharmaceuticals & Chemicals, 43, Vikas Centre, 106, S. V. Road, Santacruz (W), Mumbai-400054 | DSM Deretil S.A., Villaricos, s/n, 04618 Almeria, Cuevas Del Almanzora, Spain | Amoxicillin Trihydrate Powder, Compacted Grade A and Compacted for Direct Compression |
| 21 | 09/04/2008 | Fresh | Ruskin Chemipharm, 4/A, Bhangwadi Shopping Arcade, Kalbadevi Road, Mumbai - 40001 | GE Healthcare Limited, Corolin Road, Lower Tuffley Lane, Gloucester, GL2 6DQ, United Kingdom | 1. Ceretec (Powder for Injection 0.5 MG), 2. Amerscan Medronate II Agent (Powder for Injection 6.25 mg.), 3. Myoview (Powder for Injection 0.23 mg.) | ||
| 22 | 09/04/2008 | BD | Renewal | BD-527 30/04/2008 | APC Pharmaceuticals & Chemicals, 43, Vikas Centre, 106, S. V. Road, Santacruz (W), Mumbai-400054 | Albemarle Corporation, 451, Florida St., Baton Rouge, LA-70801, USA | Ibuprofen |
| 23 | 10/04/2008 | BD | Renewal | BD-62 31/12/2008 | Nicholas Piramal India Limited, Nicholas Piramal Tower, Ganpatrao Kadam Marg, Lower Parel, Mumbai-400013 | Bayer Health Care , D-51368 Leverkusen, Germany, having factory premises at KVP Pharma+Veterinaer Produkte GmbH, Projensdorfer strasse 324, D-24106, Germany | Toltrazuril |
| 24 | 10/04/2008 | BD | Renewal | BD-533 31/05/2008 | Signet Chemical Corporation, B/305, Neelam Centre, Hind Cycle Road, Worli, Mumbai-400025 | Bayer Health Care , D-51368 Leverkusen, Germany, having factory premises at KVP Pharma+Veterinaer Produkte GmbH, Projensdorfer strasse 324, D-24106, Germany | Flumethrin Bulk Veterinary Drug |
| 25 | 10/04/2008 | BD | Renewal | FF-172 31/12/2008 | Nicholas Piramal India Limited, Nicholas Piramal Tower, Ganpatrao Kadam Marg, Lower Parel, Mumbai-400013 | Bayer Health Care , D-51368 Leverkusen, Germany, having factory premises at KVP Pharma+Veterinaer Produkte GmbH, Projensdorfer strasse 324, D-24106, Germany | |
| 26 | 11/04/2008 | Fresh | Dr. Reddy's Laboratories Limited, Active Pharmaceutical Ingredients, 8-2-120/76/1/B, ashoka Hitech Chambers, Road No. 2, Bijendra Hills, Hyderabad-500034, Andhra Pradesh | Glaxo Operations UK Ltd., Harmire Road, Barnard Castle, County Durham, DL12 8DT, UK | 1. Cefuroxime Axetil Compacted Bulk(For Tablet Granules) | ||
| 27 | 15/4/2008 | BD | Renewal | BD-85 31/12/2008 | Refarmed Chemicals India Private Limited, S-78 Greater Kailash Part-1, New Delhi - 110048 | Ferring International Centre SA, Chemin de la Vergognausaz 50, CH-1162 St-Prex, Switzerland | Mesalazine prolonged release granules (1 gm, 2 gm) |
| 28 | 15/4/2008 | FF | Renewal | FF-64 31/12/2008 | Biochem Pharmaceuticals Industiries Ltd, Aidun Building, John Crasto Lane Mumbai-400002 | Bayer Health Care AG, Pharmaceutical Division, D-51368 Leverkusen, Germany | 1. Acarbose (Bulk), 2. Moxifloxacin Hydrochloride (Bulk), 3. Bifonazole (Bulk) |
| 29 | 15/4/2008 | BD | Fresh | Refarmed Chemicals India Private Limited, S-78 Greater Kailash Part-1, New Delhi - 110048 | Abbott Laboratories, Inc., Global Pharmaceutical Operations, 1401 Sheridan Road, North Chicago, IL 60064, USA | 1. Erythromycin Base BP/USP/EP, 2. Erythromycin Thiocyanate,3. Vancomycin Hydrochloride USP | |
| 30 | 15/4/2008 | FF | Endorsement | Ferring Pharmaceuticals Pvt. Ltd., 403/404 Sigma, Technology Street, Central Avenue, Hiranandani Gardens, Powai, Mumbai | Wyeth Medica Ireland, Little Connell, New Bridge, County Kildare, Ireland | 1. Conjugated Estrogens Tablets USP 0.625 mg (Premarin* 0.625 mg), 2. Conjugated Estrogens 0.3mg + Medroxy Progesterone Acetate 1.5mg Tablets, Premelle LiteTM 0.3/1.5, 3. Conjugated Estrogens Tablets USP 0.3 mg (Premarin* 0.3 mg) | |
| 31 | 15/4/2008 | BD | Renewal | BD-90 | Bayer Pharmaceuticals Private Limited, 1st Floor, Bayer Corporate Office, Kolshet Road, Thane-400607 | Nattermann & CIE GmbH, Nattermannallee 1, 50829 Cologne, Germany | Lecithin USP Equivalent to "Essential" phospholipids |
| 32 | 15/4/2008 | BD | Renewal | BD-38 31/12/2008 | UCB India Private Limited, 504 Peninsula Towers, G.K. Marg, Lower Parel, Mumbai-400013 | Bristol Myers Squibb Co. 4601 Highway 62 East, Mt. Vernon, Indiana 47620, USA | 1. Entecavir (Baraclude) Film Coated Tablets:- 0.5 mg, 1.0mg, 2. Entecavir (Baraclude) Oral Solution:-0.05 mg/ml |
| 33 | 15/4/2008 | BD | Endorsement | Ferring Pharmaceeuticals Pvt. Ltd., 403/404, Sigma, Technology Street, Central Avenue, Hiranandani Gardens, Powai, Mumbai- 400076 | Grenzacherstrasse 124, CH-4070 Basel, Switzerland | 1. Zalcitabine (Hivid) 0.375mg & 0.75mg Tabs., 2. Mycophenolate Mofetil (Cellcept) 200mg/1ml Suspension,3. Capecitabine (Xeloda) 500mg Tabs.,4. Daclizumab Solution for infusion (Zenepax) 25mg/5ml vials | |
| 34 | 15/4/2008 | Fresh | Refarmed Chemicals India Private Limited, S-78 Greater Kailash Part-1, New Delhi - 110048 | Roquette Freres, France having factory premises at Roquette Freres, 62136 Lestrem, France | Mannitol BP/USP/EP | ||
| 35 | 21/4/08 | BD | Renewal | BD-306 | Catalent Pharma Solution LLC., Ballon Park Road NE, Albuquerue, New Mexico, USA | Cubicin (Daptomycin) powder for concentrate for solution for infusion (350 mg/ 500 mg vials) | |
| 36 | 21/4/08 | BD | Renewal | BD-31/12/2008 | DSM Anti-Infectives India Pvt. Ltd., Bhai Mohan Singh Nagar, Toansa, The Balachur, Distt. Nawanshahr, Punjab-144533 | Yokang Bangli Medical Products Co. Ltd., Zhengjia Village, Xiangzhu Area, Yokang City, Zehjiang Province China | Medicated Surgical Bandages |
| 37 | 21/4/08 | BD | Renewal | BD-9 31/12/2008 | DSM Anti-Infectives (I) Pvt. Ltd., SCO: 86-87, Sector-8-C, Chandigarh-160018 | Wyeth Pharmaceuticals Inc. ("WPI"), 64, Maple Street Rouses Point, New York, 12979, U.S.A. | Conjugated Estrogens 0.3mg + Medroxy Progesterone Acetate 1.5mg Tablets, Premelle Lite™ 0.3/1.5 |
| 38 | 21/4/08 | BD | Renewal | BD-10 31/12/2008 | DSM Anti-Infectives (I) Pvt. Ltd., SCO: 86-87, Sector-8-C, Chandigarh-160018 | Lilly France S.A.S., Centre de Production, 2, Rue de Colonel Lilly, Zone Industrielle, F-67640, Fegersheim, France | Aimta® 100 mg (Permetrexed disodium equivalent to 100 mg Pemetrexed) |
| 39 | 21/4/08 | FF | Renewal | FF-333 31/05/2008 | GE Healthcare, Private Limited,S-46, Janta Market,Rajouri Garden,New Delhi-27 | Schering-Plough Labo n.v., Industriepark 30 - Zone A, B - 2220 Heist-op-den-Berg, Belgium | Mometasone Furoate Nasal Spray 50 mcg/dose (Nasonex) |
| 40 | 21/4/08 | BD | Fresh | Bayer Polychem India Ltd, Bayer House, Central Avenue, Hiranandani Gardens, Powai , Mumabi -400076 | Guangdong Zhaoqing Starlakw Bio-Chemical Pharmaceutical Factory, China | 1. L-Proline, 2. Inosine | |
| 41 | 21/4/08 | BD | Endorsement | Bayer Polychem India Ltd, Bayer House, Central Avenue, Hiranandani Gardens, Powai , Mumabi -400076 | Laboratori Baldacci S.P.A., via s. Michele degli Scalzi, 73- 56124 PISA, ITALY | Metadoxine | |
| 42 | 21/4/08 | BD | Fresh | Bayer Polychem India Ltd, Bayer House, Central Avenue, Hiranandani Gardens, Powai , Mumabi -400076 | Guilin Pharmaceutical Co. Ltd., No. 17 Shanghai Road, Guilin, Guangxi 541002, China | Levamisole Hydrochloride | |
| 43 | 21/4/2008 | BD | Renewal | BD-711 31/3/2011 | Anantco Enterprises Pvt. Ltd., 194, Arcind Chambers, Gauri Studio Compound, Western Express Highway, Andheri (E), Mumbai-400 069 | Lek Pharmaceuticals D.D., Trimlini 2D, 9220 Lendava, Slovenia | Clavulanate Potassium |
| 44 | 23/4/08 | Fresh | Fulford (India) Limited, Eureka Towers, B-wing, 8th Floor, Mindspace, Link Road, Malad (West), Mumbai - 400064 | LEK Pharmaceuticals D.D., Kolodvorska 27, 1234 Menges, Slovenia, Slovenia | Vancomycin Hydrohloride, Sterile USP | ||
| 45 | 23/4/2008 | FF | Fresh | Filtrex Accessories Pvt. Ltd., 201 Blue Diamond 17-18 Diamond Colony, Dr. R. S. Bhandari Marg, Indore-452001 | Lek Pharmaceuticals D.D., Perzonali 47, 2391 Prevalje, Slovenia | 1.Clavulanate Potassium-Syloid, Mixture 1:1, 2.Clavulanate Potassium-Avicel, Mixture 1:1 | |
| 46 | 23/4/2008 | FF | Endorsement | FF-17 31/12/2008 | Eli Lilly and Company (India) Private Limited, Plot No. 92, sector 32, Gurgaon, 122001, Haryana | Chiesi Farmacceutici SpA, Via Palermo,26/A-43100 Parma, Italy, | Proractant Alfa (Lung Surfactant) each 1.5 ml and 3.0ml vial contains phospholipid fraction from porcine lung 120 mg or 240 mg |
| 47 | 23/4/2008 | BD | Renewal | BD-532 31/05/2008 | Sai Quest Pvt. Ltd., 601, Siri Enclave, Srinagar Colony, Hyderabad | UCB Pharma S.A., Chemin du Foriest, B - 1420 Braine - I' Alleud, Belgium | 1.Piracetam (Oral Grade), 2. Piracetam(Injectable Grade),3. Sodium 2-Mercapto-Ethane Sulphonate (Mesna) |
| 48 | 23/4/2008 | BD | Renewal (END) | BD-33 31/12/2008 | Arun Mehra, BU Financial Controller DSM Anti-Infectives India Limited, Bhai Mohan Singh, Toansa, The. Balachaur, Distt. Nawanshahr (Punjab) | Ferring Interntional Centre SA, Chemin de la Vergognasaz , 50, CH-1162, St-Prex, Switzerland . | Mesalazine prolonged release granules(1 gm, 2 gm) |
| 49 | 24/4/08 | BD | Renewal | BD-385 31/03/2007 | Micro Labs Ltd. # 3, Quens Road, Bangalore 560001 | Edmond Pharma S. R. L., Via G. B. Grassi No. 15, 20157 Milan, Italy having factory premises at Via dei Giovi 131, 20037 Paderno Dugnano (Milan) Italy | 1. Erdosteine, 2. Indapamide, 3. Stanozolol, 4. Tenoxicam |
| 50 | 24/4/2008 | FF | Fresh | Novartis Healthcare (P) Ltd., Sandoz House, Dr. Annie Besant Road, Worli, Mumbai-400018 | DSM Anti-Infectives Chemferm , S.A.; C/ Ripolles, 2; Poligono Industrial Urvasa; Santa Perpetua de Mogoda, 08130 Barcelona, Spain | 1. Cefadroxil Monohydrate (Puridroxtm ™ | |
| 51 | 24/4/2008 | BD | Renewal | BD-528 30/04/2008 | P.D. Tolia & Co. 720, Maker Chamber # Nariman Point, Mumbai-400021 | Sichuan Pharamaceutical Co. Ltd Local No. 777 Titanfu East Road Industrial Development Zone Pengzhou Sichuan China | Penicillin G Potassium(First Crystal) |
| 52 | 24/4/2008 | BD | Renewal | BD-122 31/01/2008 | Olympia Pharma, 107, Marine chambers, 11 new Marine Lines, Mumbai-400020 | Dong -A Pharmaceutical Co. Ltd., Banwol Factrory # 434-3 Moknae-Dong Ansan City, Kyunggi- Do, Korea | 1. Epirubicin Hydrochloride BP/USP, 2. Formoterol Fumarate, 3. Cycloserine BP/USP/IP |
| 53 | 24/4/2008 | BD | Renewal | BD-513 28/02/2008 | Lubrizol advanced Materials India Pvt. Ltd.P.O.: Manjusar, Taluka: Savill, Dis. Vadodara-391775., | Lubrizol advanced materials, Inc. 9911 brecksville Road, Cleveland , Ohio-44141, USA | 1.Calcium polycarbophiln USP ( Noveon @ CA- 1 and Noceon CA-2) |
| 54 | 24/4/2008 | BD | Renewal | BD-529 30/04/2008 | Gangwal Chemicals Pvt. Ltd., 25, Diamond Plaza, Laxminarayan Shopping Center,, Mumbai-400097 | Damipharma Denmark A/S., 350-356 Englandsvej, DK-2770 Kastrup, Denmark | 1.Lactulose BP/USP |
| 38 | 22/4/2008 | FF | Fresh | Fulford India Ltd. | Schering- Plough Labo. N.V., Belgium | 1. Mometasone Furoate Natal Spray | |
| 39 | 11/04/2008 | FF | Fresh | Ferring Pharmaceutical, Mumbai | Ferring International Centre., Switzerland | 1. Mesalazine Prolong releage granules |
| APPLICATION RECEIVED FOR REGISTRATION TO IMPORT DRUGS DURING YEAR 2007-08 | ||||||||
| MONTH OF MAY 2008 | ||||||||
| S.No. | Date of Submission | Application Concerned (BD/FF) | Nature of Application (Renewal) | RC No. & Date of Expiry | Name and address of Indian agent | Name and address of manufacturing site to be registered | Name of Drugs | |
| 1 | 12/05/2008 | BD | Fresh | Gangwal Chemicals Pvt. Ltd., 25, Diamond Plaza, Laxminarayan Shopping Center, Off State Bank of India, Poddar Road, Malad(E), Mumbai-400092 | Fuji Chemical Industry Co., Ltd., having premises at 55 Yokohoonji, Kamiichi, Nakaniikawa, Toyama, Japan, 9300397, Gohkakizawa Factory: 1. Gohkarkizawa, Kamichi, Nakanilkawa, Toyama, Japan, 9300397 | Neusilin (Magnesium Aluminometasilicate) | ||
| 2 | 02/05/2008 | BD | Renewal | BD-106 31/12/2008 | Sicor S.r. l. having manufacturing premises at Via Terazzano, 77-20017 Rho(MI)-Italy | Teva API India Limited, Suite 339,Kailash Plaza, Vallabhbaug Lane,Ghatkopar (East) Mumbai-400077 (INDIA) | 1.Atracurium Besylate, 2.Bclomethasone Dipropionate Anhydrous,3.Bleomycin Sulphate, 4.Fluorometholone Micronized, 5.Pancuronium Bromide, 6.Triamcinolone Micronized, 7. Triamcinolone Acetonide Micronized Sterile, 8.Vecuronium Bromide | |
| 3 | 02/05/2008 | BD | Renewal | BD-42 31/01/2009 | GlaxoSmithKline Pharmaceuticals Limited, Dr. Annie Besant Road, Mumbai-400025 | 1. Amoxicillin Sodium: Potassium Clavulanate 5:1 Blend Sterile, 2. Mupirocin USP, 3. Steriletimentin Blend (Ticarcillin Disodium and Clavulanate Potassium 30:1 Sterile Blend), 4. Mupirocin Calcium | ||
| 4 | 02/05/2008 | FF | Renewal | FF-97 31/12/2008 | GE Healthcare Pvt. Ltd., S-46, Janta Market, Rajouri Garden, New Delhi-1100027 | GE Healthcare Ireland, IDA Business Park, Carrigtohil, Co. Cork, Ireland | 1. Iohexol Injection USP 180mgl/ml,240mgl/ml,300mgl/ml and 350mgl/ml(Brand:Omnipaque ™), 2. Iodixanol Injection 270mgl/ml and 320mgl/ml (Brand: Visipaque ™), 3. Gadodiamind Injection 0.5 mmol/ml (Brand: Omnisan ™) | |
| 5 | 02/05/2008 | FF | Fresh | KMS Medisurgi Pvt. Ltd., 44, Mangaldas Road, Bulakhidas Building, Ground Floor, Mumbai-40002 | Chensin Packing Industry Co. Ltd., No.7, Lane 33, Da Pu Road, San Hsia, Taipei Hsien, Taiwan, R.O.C. | 1. Skin Barrier Microporous Surgican Tape | ||
| 6 | 02/05/2008 | BD | Renewal | BD-106 | Regent Drugs Limited, Suite 339, Kailash Plaza, Vallabaug Lane, Ghatkopar (E), Mumbai-400077 | Sicor S.p.A, Via Terazzano, 77-20007, RHO (MI), Italy | 1. Atracurium Besylate, 2. Beclomethasone Dipropionate Anthydrous Micronized USP/EP/JP, 3. Bleomycin Sulphate USP/EP, 4. Budesonidemicronized Pheur, 5. Desonide, 6. Fluorometholone Micronized USP/JP, 7. Pancuronium Bromide PH.EUR., 8. Triamcinolone Micronized USP/EP, 9. Triamcinolone Acetonide Micronized /Sterile USP/EP, 10. Vencuronium Bromide | |
| 7 | 04/05/2008 | FF | Renewal | FF-124 31/01/2009 | Ferring Pharmaceuticals Pvt. Ltd., 403/404 Sigma, Technology Street, Central Avenue, Hiranandani Gardens, Powai, Mumbai-400076 | Ferring GMBH, Wittland 11, D-24109 Kiel, Germany | 1. Triptorelin Acetate Injection 3.75 mg 9 Decapeptyl Depot/CR, 2. Triptorelin Acetate Injection 0.1 mg (Decapeptyl 0.1 mg/Decapaptyl Daily), 3. Chorionic Gonadotrophin Injection 5000IU (Choragon 5000), 4. Menotrophin Injection 751.U. (Menogon/Menopur), 5. Somatostatin Injection 3 mg (Somatostatin 3mg Ferring) | |
| 8 | 05/05/2008 | FF | Renewal | FF-46 31/12/2008 | Fresenius Kabi (I) Pvt. Ltd., 6-E, Heritage House, Ramabai Ambedkar Road, Pune-411001 | Fresenius Kabi Deutschland GmbH, Freseniusstrabe 1, 61169 Friedberg, Germany | 1.Hydroxy Ethyl Starch 6% 250ml & 500ml (Voluven), 2. Amino Acid Sodlution for Interavenous use 1000ml, 1500 ml & 2000ml (Aminomix I) | |
| 9 | 05/05/2008 | BD | Fresh | Shilpa Medicare Limited, 10/80, Rajendra Gunj, Raichr - 584102 | ICE s.r.l. Industria Chemica Emiliana Via Sicilia 8,10 42100 Reggio Emilia, Italy | 1. Ursodexycholic Acid | ||
| 10 | 05/05/2008 | FF | Renewal | FF-53 31/12/2006 | Fresenius Kabi (I) Pvt. Ltd., 6-E, Heritage House, Ramabai Ambedkar Road, Pune-411001 | Fresenius Kabi AB, S-75174, Uppsala, Sweden | 1. Kabiven (Intravenous Amino Acids and Intravenous Fat Emulsion Solutiion for Parentral Nutrition) 1026ml, 1540ml, 2053ml & 2566ml, 2. Structolipid 20% (Intravenous Fat Emulsion for Parenteral Nutrition) 250ml & 500ml | |
| 11 | 06/05/2008 | BD | Renewal | BD-87 31/12/2008 | GlaxoSmithKline Pharmaceuticals Limited, Dr. Annie Besant Road, Mumbai-400005 | Glaxo Operations UK Ltd.,Priory Street, Ware, Hertfordshire, SG120DJ, UK | 1. Sulbutamol BP/USP/IP, 2. Beclomethasone Dipropionate (Solvated Micronised; Hydrated-Micronised), 3. Fluticasone Propionate, 4. Salmetrol Xinafoate | |
| 12 | 06/05/2008 | BD | Renewal | BD-43 31/01/2008 | GlaxoSmithKline Pharmaceuticals Limited, Dr. Annie Besant Road, Mumbai-400025 | Glaxo Operations UK Limited, North Lonsdale Road, Ulverston, Cumbria, La 129DR, UK | 1. Cefuroxime Sodium USP/BP, 2. Ceftazidime for Injection USP/BP | |
| 13 | 06/05/2008 | FF | Renewal | FF-125 31/01/2008 | Ferring-Leciva A.S., K Rybniku 475, 252 42 Jesenice U Prahy, CZECH Republic | Ferring Pharmaceuticals Private Limited, 403/404 Sigma, Technology Street, Central Avenue, Hiranandani Gardens, Powai Mumbai-400076 | Terlipressin Injection 0.2 MG, 0.5 MG and 1.0 MG (Remestyp 0.2, 0.5 & 1.0) | |
| 14 | 06/05/2008 | FF | Renewal | FF-26 31/12/2008 | GlaxoSmithKline Pharmaceuticals Limited, Dr. Annie Besant Road, Mumbai-400025 | Glaxo Operations UK Ltd.,Priory Street, Ware, Hertfordshire, SG120DJ, UK | 1. Fluticasone Propionate 500 mcg/250mcg/100mcg + Salmeterol 50mcg (Seretide Accuhaler), 2. Lamivudine 150mg+Zidovudine 300mg (Combivir Tablets), 3. Hepitec Tablets 100mg (Lamivudine Tablets) | |
| 15 | 12/05/2008 | FF | Endorsement | FF-367 31/03/2009 | Bristol -Mayers Squibb India Pvt Ltd.,A Block,First Floor, Shiv Nagar Estate ,Dr.Annie Besant Road,Worli,mumbai-400018,INDIA | Bristol -Mayer Squibb S.r.l. Via Del Murillo Km 2,800Sermoneta(Latina)Italy. | 1.Taxol(Paclitaxel) Injection,30 mg, 100mg, 300mg vials. 2.Paraplatin(CarboplatinAqueousSolution)Injection. 50mg/5ml, 150mg/15ml, 450mg/45ml | |
| 16 | 12/05/2008 | BD | Fresh | Roche Scientofic Company (India) pvt. Ltd, 2nd floor , Dr. Annie Besant Road, Mumbai-400018 | F. Hoffmann-La Roche Ltd. (FHLR) Grenzacherstrasse 124, CH 4070, Basel, Switzerland having factory premises at DSM Nutritional Products Ltd., Branch Site Sisseln, Hauptstrasse 4, 4334, Sisseln, Switzerland | 1.Clonazepam bulk Ph. Eur. | ||
| 17 | 12/05/2008 | BD | Renewal | BD-51 31/12/2008 | Serdia Pharmaceuticals (India) Pvt. Ltd., Serdia House off, Dr. S.S. Rao Road, Parel, Mumbai-400012 | Servier Egypt Industrial Zone, Block No. 37, Six of Oct. City, Giza, Egypt | 1. Indapamide | |
| 18 | 12/05/2008 | BD | Renewal | BD-49 31/12/2008 | Serdia Pharmaceuticals (India) Pvt. Ltd., Serdia House off, Dr. S.S. Rao Road, Parel, Mumbai-400012 | Les Laboratoires Servier, Division ORIL Industrie, 13, rue Auquste Desqenetails, BP 17- 76210 Bolbec , France | 1. Trimetazidine Dihydrochloride, 2. Perindopril/ tert- Butylamine, 3. Piribedil, 4. Micronised Purified Flavonoids with 90% Diosmine, 5. Sulbutiamine, 6.Gliclazide, 7. Tianeptine Sodium | |
| 19 | 12/05/2008 | BD | Endorsement | BD-624 | Arun & Co., 603 Polaris, Off Marol Maroshi Road, Marol, Andheri (East), Mumbai-40005 | Institut Rosel/ Lalleman S Inc, 8480 Saint Lairent Boulevard, Montreal, Quebec, Canada H2P 2M6 | 1. Lp 299 v X Capsules | |
| 20 | 15/5/2008 | BD | Renewal | BD-28 31/12/2008 | Solavay Pharm India Ltd, Suraj Prakash, 86 Shankar Marg, Prabhadevi, Mumbai-400025 | Solay Pharmaceuticals B.V., C.J.Van Houteniaan 36, 1381 CP Weesp, The Netherlands | 1. Betahistine Di Hydrochloride( Betahistome HydrpchlorideIP), 2. Dydrogesterone Granules, 3. Mebeverine Hydrochloride IP, 4. Fluvoxamine Maleate BP, 5. Lactulose Concentrate USP, 6. Lactulose Solution USP | |
| 21 | 16/5/2008 | FF | Renewal | FF-69 31/12/2008 | Fresenius Kabi India Private Limited | Fresenius Kabi Austria GmbH, Hafnerstrasses 36,A- 8055, Graz, Austria | 1.Propofol Injection % I.V. (Fresofol), 2.Vamin Glucose, 3.Vitrimix KV, 4.Aminosteril N Hepa8%, 5.Nephrosteril, 6.Omegaven 10%, 7. Intralipid 10%& 20%, 8. Intralipid PLR 10% , 9. Aminoven Infant10%, 10. Dipeptiven, 11. Lipovenous MCT10% & 20%, 12. Aminoven 5% & 10% | |
| 22 | 13/5/2008 | FF | Endorsement | FF-196 | Candila Healthcare Ltd., Zydus Tower, Satellite Cross Roads, Ahmedabad-380015 Gujarat. | Schering Gmbh & Co. Produktions KG Doebereinerstrasse 20, 99427 Weimar, Federal Republic of Germany | 1. Yasmin 21 Tablets( Drospirenone 3.0mg and Ethinylestradiol 0.03mg) | |
| 23 | 16/5/2008 | FF | Endorsement | FF-78 31/12/2008 | B.Braun Medical (India) Pvt. Ltd. Unit No. 1, 5th Floor, East Quadrant, The IL & FS Finanicial Centre, Bandra Kurla Comploex, Bandra (east), Mumbai-400051 | B.Barun Medical Ind. SDN. BHD. Bays, Free Industrial Zone, 11900 Penang Malaysia | 1. 0.9% NaCI 5ml, 20ml MP, 2. WFI 5ml, 10ml, 20ml MP, 3. 20% NaCI 10ml,20ml MP, 4. 50% Glucose 10l,20ml MP, 5. 14.9% KCI 10ml, 20ml MP, 6. 7.45% KCI 10ml, 20ml MP, 7. 5.85% NaCI 10ml, 20ml MP | |
| 24 | 16/5/2008 | FF | Endorsement | EF-413 1/07/2005 | BSN Medical pvt. Ltd. 302 Sarjan Plaza, 100, Annie Besant Road, Woril, Mumbai-400018. | BSN Medical GmbHn & Co., Heykenaukamp 10, 21147 Hamburg, Germany . | 1. Cultimed Gel | |
| 25 | 16/5/2008 | BD | Renewal | BD-548 1/07/2005 | Hindustan Latax Limited, Kanagala-591225, Belagaum Dist, Karnataka State | Beijing Zizhu Pharmaceutical Company Limited,27, Chaoyang North Roa, Chayoang Dist, Beijing-100024, China | 1. Ethinyloestradiol USP | |
| 26 | 16/5/2008 | FF | Endorsement | FF-353 31/12/2008 | Fulford (ndia) Limited, Eureka Towers, B-wing, 8th Floor, Mindspace, link Road, Malad (West), Mumbai-400064. | Orion Corporation Orion Pharma Turku Plant Tengstrominkatu 8, P.O. Box 425 20101 Turku Finland | 1. Temozolomide Capsule (Temodal) 140mg and 180mg | |
| 27 | 16/5/2008 | FF | Fresh | Smith & Nephew Medical Ltd., P.O. Box 81, Hessle Road, Hull Hu3 2Bn, England, U.K | Smith & Nephew Medical Ltd., P.O. Box 81, Hessle Road, Hull Hu3 2Bn, England, U.K. having factory premises at Nucryst Pharmaceuticals Corporation, 10102-114thStreet, Fort Saskatchewan, Alberta, Canada | 1. Acticoat- Sterile Disposable Dressing | ||
| 28 | 21/5/2008 | BD | Renewal | BD-79 31/12/2008 | Daiwat Chemicals, 407 Centrepoint , Andhri- Kuria Road, Andheri(E) Mumbai-400059 | Pfizer PGM Zone Industrielle-29 route des Industries 37350, Police Sur Cisse, France | 1. Fenofibrate | |
| 29 | 21/5/2008 | FF | Renewal | FF-342 31/12/2008 | Pfizer PGM, Limited Profizer Centre, Jogeshwari(west) Mumbai-400102. | Terhormon S.R.L.- Industrial Chimica Biologica, Via , Nibbola,28070 Terdobblate (No.), ITALY | Sildenafil Citrate 25mg and 100 mg Tablets | |
| 30 | 21/5/2008 | BD | Renewal | BD-81 31/12/2008 | Daiwat Chemicals, 407 Centrepoint , Andhri- Kuria Road, Andheri(E) Mumbai-400059 | Croma Pharma GmbH, Industriezeile 6, A-2100 Leobendorf, Austria | 1. Pancreatin | |
| 31 | 22/5/2008 | FF | Renewal | FF-303 30/11/2007 | Surgicon Healthcare Pvt. Ltd, 611 Sakar V, Behind Nataraj Cinema, Ashram Road, Ahmedabad -380009 | Ben Venue Laboratories Inc., 300 Northfield Road, Bedford Ohio 44146, USA | 1.Sodium Hyaluronate1.8% Injection 2. Hydroxypropylamethy Cellulose 2% Solution | |
| 32 | 22/5/2008 | BD | Renewal | BD-279 30/09/2006 | Forum Products Ltd. Logix Park, A-4&5, 16, Nodia, U.p-201301 | Siegried Ltd. Untere Bruhlstrasse 4 CH-4800 Zofingen Switzerland | Oxicinazole Nitrate (Microniseo) | |
| 33 | 27/5/2008 | FF | Renewal | FF-128 2/03/2009 | Fulford (ndia) Limited, Eureka Towers, B-wing, 8th Floor, Mindspace, link Road, Malad (West), Mumbai-400064. | Nanjing Organon Pharmaceutical Company Ltd. Pukou High-Tech Development Zone, P.O. Box 3209-27 Nanjing-210032 | 1. Doxorubicin Hydrochloride Pegylated Liposomal Injection I.V (Caelyx) 20mg/50mg | |
| 34 | 27/5/2008 | MD | Renewal | MD-1 2/03/2009 | Organon(India) Limited, 7 Wood Street, Kolkata 700016 | Croma Pharma GmbH, Industriezeile 6, A-2100 Leobendorf, Austria | Intra Uterine Contraceptive Devices (Multiload Cu 250 & Cu 375 Radio- Opaque | |
| 35 | 12/05/2008 | FF | Endorsement | FF-367 31/03/2009 | Bristol Mysers India Pvt. Ltd., 1st Floor, 'A' Block, Shiv Sagar Estate, Dr. Annie Besant Road, Worli, Mumbai-400018 | Bristol -Mysers Squibb S.r.l., via del Murillo Km 2,800 Sermoneta (Latina) Italy | 1. Taxol(Paclitaxel) Injection 30mg, 100mg vial, 300mg vial, 2. paraplatin (Carboplatin Aqueous Solution) Injection 50mg/5ml, 150ml/ 15 ml & 450mg/45 ml | |
| 36 | 05/05/2008 | BD | Fresh | Shilpa Medicare Ltd., Raichur | ICE S.R.L., ITaly | 1. Urosodeoxy-Cholic Acid | ||
| 37 | 05/05/2008 | BD | Fresh | Roche Scientific Company, Mumabi | DSM Nutritional Product, Switzerland | 1. Clonazepam |
| APPLICATION RECEIVED FOR REGISTRATION TO IMPORT DRUGS DURING YEAR 2007-08 | |||||||||||||
| MONTH OF JULY 2008 | |||||||||||||
| S. NO. | Date of Submission | Application Concerned (BD/FF) | Nature of Application (Fresh, Endorsement, Renewal) | RC No. & Date of Expiry | Name and address of Indian agent | Name and address of manufacturing site to be registered | Name of Drugs | ||||||
| 1 | 01/07/2008 | FF | Fresh | M/S Bristol Mysers Squibb India Pvt. Ltd., 1st Floor, A Block, Shiv Sagar Estate, Dr. Annie Besant Raod, Worli, Mumbai-400018 | M/S Bristol Myhers Squibb Holdings Pharma, Ltd. Liability Co. Route 686, Km.2.3, Manati, Puerto Rico-00674 | 1. Abatacept (Orenica®) for Inj. 250mg/vial | |||||||
| 2 | 01/07/2008 | FF | Renewal | FF-16 31/12/2008 | M/S Organon (India) Ltd., 7 Wood Street, Kolkata-700016 | M/s Organon S.A Usine Saint-Charles 60590 Eragny sur Epte, France | 1.Rocuronium Bromide Injection (Esmerson 50mg=5ml), 2. Vecuronium Bromide Injection (Norcuron 4mg) | ||||||
| 3 | 01/07/2008 | BD | Renewal | BD-136 28/02/2009 | M/S Ranbaxy Laboratories Ltd., 12th Floor Devika Tower, Nehru Place, New Delhi-110019, Corporate Office Plot no:90, Sector- 32, Gurgaon, Haryana-122001 | M/S LEO Pharmaceutical Products Ltd. A/S (LEO Pharma A/S), 55 Industriparken, DK-2750, Ballerup, Denmark. | 1.Fusidic Acid(Bulk), 2. Sodium Fusidate(Bulk) | ||||||
| 4 | 01/07/2008 | FF | Renewal | FF-137 28/02/2009 | M/S Ranbaxy Laboratories Ltd., 12th Floor Devika Tower, Nehru Place, New Delhi-110019, Corporate Office Plot no:90, Sector- 32, Gurgaon, Haryana-122001 | M/S LEO Pharmaceutical Products Ltd. A/S (LEO Pharma A/S), 55 Industriparken, DK-2750, Ballerup, Denmark. | 1.Innohep Injection (a) 10,000 Anti-XA IU/ML in Prefilled Syringes of 0.45ml (b)10,000 Anti-XA IU/ML in Prefilled Syringes of 0.35ml, (c.) 20,000 Anti-XA IU/ML in Prefilled Syringes of 0.50ml, (d) 20,000 Anti-XA IU/ML in Prefilled Syringes of 0.70ml, (e)10,000 Anti-XA IU/ML in 2 ml vials, (f) 20,000 Anti-XA IU/ML in 2 ml vials | ||||||
| 5 | 01/07/2008 | FF | Renewal | FF-367 31/03/2009 | M/S Bristol Mysers Squibb India Pvt. Ltd., 1st Floor, A Block, Shiv Sagar Estate, Dr. Annie Besant Raod, Worli, Mumbai-400018 | M/S Bristol Myhers Squibb S.r.l Via Del Murillo, Km 2.800, 04010 Sermoneta, Latina, Italy | 1.Cefepime Injection each vial contains: Cefepime HCL……..2gm | ||||||
| 6 | 02/07/2008 | FF | Renewal | FF-370 31/03/2009 | M/S Eli Lilly and Co. (India) Pvt. Ltd, Plot No. 92, Sector 32, Gurgaon, 122001 Haryana, | M/S Cilag AG, Hochstrasse 201, CH-8205, Schaffhausen, Seitzerland | 1. Reopro(Inj. Abciximab 10mg/5ml) | ||||||
| 7 | 02/07/2008 | FF | Endorsement | FF-401 31/10/2009 | M/S Novartis Healthcare Pvt. Ltd, Sandoz House, Dr. Annie Besant Road, Worli , Mumbai-400018 | M/S Novartis Pharma Stein AG, Schaffhauserstrasse, 4332 Stein, Switzerland | 1.GalvusMet (vildagliptin/metformin hydrochloride) fixed dose combination tablet | ||||||
| 8 | 02/07/2008 | FF | Endorsement | FF-84 31/12/2008 | M/S Glaxo Smith Kline Pharmaceuticals Ltd., Dr. Annie Besant Raod, Mumbai-400030 | M/S Glaxo Smith Kline Australia Pvt. Ltd., 1061 Mountain Highway, Boronia 3155, Australia | 1. Ventorlin Inhaler (Salbutamol Inhaler) | ||||||
| 9 | 02/07/2008 | FF | Endorsement | FF-116 31/10/2008 | M/S Johnson & Johnson , 30 Forjett Street, Mumbai-400036 | M/S Janseen Pharmaceutica NV, Turnhoutseweg 30, B-2340 Beerse, Belgium | 1.Yondelis (Trabectedin 1mg vial) | ||||||
| 10 | 02/07/2008 | FF | Fresh | M/S Ranbaxy Laboratories Ltd., 12th Floor Devika Tower, Nehru Place, New Delhi-110019 | M/S Ansto Radiopharmaceuticals and Industrials, Australia | 1.SIR spheres microspheres along with V-vial SIR sphere delivery set, delivery box, V-vial holder, syringe shield | |||||||
| 11 | 04/07/2008 | FF | Fresh | M/S Adlife Healthcare Pvt. Ltd., 2B-002, Suncity, Phase 1, Thankur Village, Kandivali (E), Mumbai-400101 | M/S Isei co., Incorporated, 13-45 Wakaba cho, Yamagata-City,Yamagata, 990-2495 Japan. | 1. Mecobalamin JPC 500 mcg./ml Inj.(Isecobamin) One ml Ampule in an individual pack. | |||||||
| 12 | 08/07/2008 | BD | Renewal | BD-167 31/03/2009 | M/S Sanofi-Synthelabo (India) Ltd., 54/A Sir Mathuradas Vasanji Road, Andheri(East), Mumbai-400093 | M/S Sanfoi Chimie, Route D Avignon, 30390 Aramon, France | .1. Amiodarone Hydrochloride | ||||||
| 13 | 08/07/2008 | BD | Endorsement | BD-216 31/03/2009 | M/S Esschem (Pvt.) Ltd., 19th Floor, Centre-1, World Trade Centre, Cuffe Parade, Mumbai-400005 | M/S Dipharma Francisn S.R.L.., Via Bissone 5, 20021 Barazatedi Bollate (MI), Italy having factory premises at M/S Dipharam Francis S.R.L., Via Origgio, 23,21042 caronno Pertusella (VA), Italy | 1. Fexofenadine Hydrochloride | ||||||
| 14 | 08/07/2008 | BD | Renewal | BD-40 31/12/2008 | M/S Solvay Pharma India Ltd., Suraj Prakesh,86, Shankar Ghanekar Raod, Prabhadevi, Mumbai-400025 | M/S Solvay Pharma 42, Rue Rought de Lisle-B.P. 22, F-92151 Suresnes Cedex, France(Marketed thru Solvay Pharmaceutiacals Marketing and Licensing AG, Binningerstrasse 94,4123 Allschwi, Switzerland)having factory premises at M/S Solvay Pharmaceuticals, Route de Belleville-Lieu-mdit Maillard, F-01400 Chatillion-Chalaronne, France | 1. Pinaverium Bromide | ||||||
| 15 | 08/07/2008 | BD | Renewal | BD-94 31/12/2008 | M/S Privi Pharma Pvt. Ltd., 701, Makhija Chambers , 196, Turner Road, Bandra (West), Mumbai-400050 | M/S Congnis Australia Pvt. Ltd., 71-77 Taunton Drive, Cheltenham VIC 3192, Australia | 1. Betatene® 7.5 % N Beadlets(Natural Mixed Carotenoids), 2.Betatene® 20 % Soy (Natural Mixed Carotenoids), 3. Betatene® 30 % Soy (Natural Mixed Carotenoids) | ||||||
| 16 | 08/07/2008 | FF | Renewal | FF-339 30/05/2008 | M/S Sandoz Pvt. Ltd., Sandoz House, Dr. Annie Besant Road, Worli, Mumbai-400018 | M/S RP Scherer GmbH & Co., KG Gammelsbacher Straβe 2, 69412, Germany | 1. Clofazimine Soft Gelatine Capsules 50mg & 100mg | ||||||
| 17 | 08/07/2008 | BD | Renewal | BD-218 30/06/2009 | M/S Esschem (Pvt.) Ltd., 19th Floor, Centre-1, World Trade Centre, Cuffe Parade, Mumbai-400005 | M/S Zhejiang East-Asia Pharmaceutical Co., Ltd., Economic Development Zone of Sanmen Country, Zhejiang, China P.C-317100 | 1. Ofloxacin BP/USP, 2. Levofloxacin Hemihdrate, 3. Ketoconazole BP/USP | ||||||
| 18 | 08/07/2008 | FF | Renewal | FF-135 28/02/2009 | M/S Solay Pharma India Ltd., Suraj Prakesh, 86, Shankar Ghanekar Road, Prabhadevi, Mumbai-400025 | M/s Instituto Massone S.A. Arias 4431, C1430CSE, Buenos Aires, Argentina | (A.) Human Chorinic Gonadotrophins Inj. IP9HCG0 5000IU (1.) Life 5000 (B.) Follicle Stimaultaing BP (FSH) Inj. (Uroflollitrophin Inj. BP)(1.) Puregon 75 (2.) Puregon 150 (C.) Follicle Stimulating Hormone (FSH) and Luteinsing Hormoine (LH) Inj. (Menotrophin Inj. BP) (HMG) (1.) Nugon 75, (2.) Nugon 150 | ||||||
| 19 | 08/07/2008 | BD | Renewal | BD-19 301/12/2008 | M/S Mediline Add. 39, Nandghanshyam Industrial,Estate Off. Mahakali caves road, Andheri (E)Mumbai-400093 | M/S Chifeng Pharmaceutical Co., Ltd., 84, Yidong Street, Hongshan District , Chifeng, Inner Mongolia, China | 1. Griseofulvin , 2. Oxytetracycline Dihydrate (Base), 3. Oxytetracycline Hydrochloride, 4. Riboflavin (Vitamin B2) | ||||||
| 20 | 08/07/2008 | BD | Endorsement | BD-211 30/06/2009 | M/S APC Pharmaceuticals & Chemicals, 43 Vikas Centre, 106, S.V. Road, Santa Cruz (West), Mumbai-400054 | M/S Zhejiang Hisum Pharmaceutical Co., Ltd., 1 Haizheng Avenue, Jiaojiang District, Taizhou City, Zhejiang Province, China having Premises at M/S Zhejiang Hisum Pharmaceutical Co., Ltd., 46 Waisha Road, Jiaojiang District,Taizhou City, Zhejiang Province,PRC | 1. Imipenem and Cilastatin | ||||||
| 21 | 08/07/2008 | BD | QL | M/S Corus Generics, 177A- 2 (first floor), Jeewan Nagar, New Delhi-110014 | M/S Ribbon S.R.L. Via G. Prati-4,20145Milano, Italia having factory premises at Ribbon S.R.L., Via San Leonardo 23, 45010 Villadose(RO), Italia | 1. Ceftrizxone sodico sterile | |||||||
| 22 | 11/07/2008 | FF | Renewal | FF-356 14/12/2008 | M/S USV Ltd., B.S.D. Marg, Govandi, Mumbai-400088 | M/S Finzelberg GmbH & Co. Kg. Koblenzer strasse 48-56 D-56626, Andernach | 1. Dried Ivy Leaf Extract | ||||||
| 23 | 11/07/2008 | FF | Renewal | FF-70 31/12/2008 | M/S Life Sciences India Pvt. Ltd., LG House, AB-3, Safdarjung Enclave, New Delhi--110029 | M/s 601, Yongje-Dong, Iksan- city, Jeonbuk- do, korea | 1. Sodium Hyaluronate 1% Solution (Intrinsic Viscosite 3-5.5M3/Kg | ||||||
| 24 | 11/07/2008 | BD | Endorsement | BD-79 31/12/2009 | M/S Esschem (Pvt.) Ltd., 19th Floor, Centre-1, World Trade Centre, Cuffe Parade, Mumbai-400005 | M/S Laboratorio chimico Internazionale S.P.A Via Benvenuto Cellini-2020090 Segrate (MI), Italy | 1. Gliclazide, 2. Flupentixol Decanoate | ||||||
| 25 | 16/7/2008 | BD | Renewal | BD-118 31/1/2009 | M/S Dishman Netherlands B.V. Nieuweweg 2A, 3901 BE Veenendaal, The Netherlands | M/S Dishman Netherlands B.V., C.J. Van Houtenlaan 36, 1381 CP Weesp,The Netherlands | 1. Calcitriol, 2. Alfacalcidol | ||||||
| 26 | 16/7/2008 | FF | Renewal | FF-147 31/03/2009 | M/S Bharat Serums and Vaccines Ltd., 17th Floor , Hoechest House, Nariman Point, Mumbai-400021 | M/S Ispen Biopharam Ltd., Ash Road, Wrexham Industrial Estate, Wrexham LL 139 Uf, United Kingdom | 1. Dysport Injection 500 units(Clostridium Botulimum Type-A toxin Haemagglutinin complex) | ||||||
| 27 | 11/07/2008 | FF | Fresh | M/S Anita International Pvt. Ltd., A-11 First Floor, Kailash Colony, New Delhi-110048 Mez Hemkunt Tower, Nehru Place, New Delhi-110019 | M/S Alpharam APS , Dalslandsgade 11, 2300 Copenhagen S, Denmark having factory premises at Aurisco Pharmaceuticals Pvt. No. 22, Fengze Road Tiantai, Zhejiang Province 317200 Peoples Republic of China | 1. Fluticasone Propionate | |||||||
| 28 | 14/7/2008 | BD | Fresh | M/S Prime Medica Promotion Pvt. Ltd.,107, Neelkanth Estate No. 1, Sativali, Vasai (East) Distt.-Thane-401208 | M/S Prime Medical Inc., 291-3, Cheongvo-Ri, Biong-Myon, Hwaseeong-shi, Gyeonggi, Korea | 1. Synthetic Casting Tape, 2. Prime Splint | |||||||
| 29 | 02/07/2008 | BD | Renewal | BD-552 | M/S Archerchem, Unit No. 211 & 212, 2nd Floor, Linkway Estate Premises CHS Ltd., Malad Link Road, Malad [W], Mumbai-400064 | M/S Synbias Pharma Ltd., Prospert Panfilova 15, Donetsk, Ukraine, 83114 having premises at Roza Luksemburg SG 70,Donetsk, Ukraine, 83114 | 1. Doxorubicin Hydrochloride EP, 2. Idarubicin Hydrochloride USP, Epirubicin Hydrochloride EP | ||||||
| 29 | 22/7/2008 | FF | Endorsement | M/S Ferring Pharmaceutical Pvt. LTd., 403/404, Sigma , Technology Steet, Central Avenue, Hiranandani Gardens, Powai, Mumbai-400076 | M/S Ferring International Centre SA Chemie de la Vergognausaz, 50CHi1162, St-Prex, Switzerland | 1. Desmopressin Tablets (0.1 mg, 0.2mg), 2. Mesalazinew Prolonged Release Tablets (500 mg) | |||||||
| 30 | 23/7/2008 | FF | Renewal | FF-354 | M/S Flder Pharmaceutical Ltd., Elder House, Plot No. C-9 Dalia Industrial Estate, Off, Veera Desai Read, Andheri (W), Mumbai-400053 | M/S Patheon Italiua S.p.a, Viale G. B Sreuccji 110, 20052 Monza (mni), Italy and Sirton Pharmacautrical s.p.a., Pizza XX Settembre 2, 22079 Villa Guardia (co) Italy | |||||||
| 31 | 03/07/2008 | FF | Renewal | FF-103 | M/S Organon (India) Ltd., 7 Wood Street, Kolkata-700016 | M/S organon (Ireland) ltd.P.O. Box 2857 Drynam Road, Swords co. Dublin Ireland | 1. Ganirelix solution for Inj. 0.25 mg per 0.5 ml (Orgalutran), 2. Follitropin beta (FSH) Inj. 300IU/600IU, 3. Estriol Cream (Ovestin/Evalon cream) , 4. Contraceptive vaginal ring containing 11.7 mg etonogestrel and 2.7 mg ethinylestradiol (Nuval Ring) | ||||||
| 32 | 25/7/2008 | BD | Endorsement | BD-531 31/05/2011 | M/S Nayyar medicine Co., A-29, 3rd Floor, Sanjay Nagar, Mangolpur Kalan Delhi- 110085 | M/S Zhejiang Jiangbei Pharmaceutical co. ltd., Dongdai Village, Zhangan Street, Jiaojiang Zone, Taizhou City Zhejiang Province, China | 1. Levetiracetam (Enterprises Standard) | ||||||
| 33 | 23/7/2008 | BD | Fresh | M/S Sun Pharmaceutical Industries Ltd., Tandalja Vadodara, Gujarat -390020 | M/S Alkaloida Chemical Company Zrt. 4440 Tiszavasvari, Kabay Janos u. 29 | 1. Codeine Phosphate Hemihydrate | |||||||
| 34 | 23/7/2008 | FF | Renewal | M/S DPB Antibiotics, Ganesh Corporation, Office No.19, Hissa No. 4 & 5, Khandagale Estate, Purna Village, Bhiwandi-421302, Dist. Thane, Maharashtra | M/S Hebei Huaxu Pharmaceutical Co. Ltd., No. 62, Tangu North Street, Shijiazhuang City, Hebei, China | 1. Mannitol Cp/Bp/Usp | |||||||
| 35 | 23/7/2008 | FF | Renewal | FF-144 28/02/2009 | M/S Lundbeck India Pvt. Ltd., Esteem Regency, II Floor, 6/A Richmond Road, Bangalore-560025 | M/S H. Lundbeck A/S, 9 Ottilliavej DK-2500 Valby, Copenhagen, Denmark | 1. Cipralex Tablet (a.) Escitalopram Oxalate-5mg, 10mg & 20mg, 2. Fluanxol Depot Injection: (a.)Flupentrixol Decanoate Injection- 20mg/ml & 40 mg/ 2 ml, 3. Clopixol Acuphase Injection: (a) Zuclopentixol Acetate Injection- 50mg/ ml & 100mg/2ml, 4. Clopixol Depot Injection : (a) Clopixol Depot Injection: (a) Zuclopenthixol Decanoate Injection- 200mg/ml | ||||||
| 36 | 23/7/2008 | FF | Fresh | M/S Indocoar Pharma Pvt. Ltd., No. 32, 1st Main Road, Lower Palace Orchards, Bangalore-560003 | M/S Icure Pharmaceutical Inc., 221-4, Sinneung-ri, Seoun-myeon, Anseong-si, Gyeonggi-do- 456853, Korea | 1. Dicolofenac Diethylammaonium 120mg (Plaster), 2. Felbinac 35 mg (Plaster), 3. Flurbiprofen 20mg (Plaster), 4. Ketorprofen 30mg (Plaster), 5. Nicotine Transdermal System USP 30- (Patches) (Nicotine 19, 38, 57 mg) | |||||||
| 37 | 23/7/2008 | BD | Fresh | M/S Solvay Pharma India Ltd., Suraj Prakesh,86, Shankar Ghanekar Raod, Prabhadevi, Mumbai-400025 | M/S Solvay Pharmaceuticals B.V., C.J. Van Houtenlaan 36, 1381 CP Weesp, The Netherlands | 1. Betahistine di hydrochloride (Betahistine Hydrochloride IP) | |||||||
| 38 | 24/07/2008 | BD | Renewal | BD-30 31/12/2008 | M/S AstraZeneca Pharma India Ltd., Avishkar, P.B No. 2483, Off Bellary Road, Hebbai, Bangalore-560024 | M/S. AstraZenenca Operations, Bulk Production, Sweden, AstraZeneca Sverige AB,S-151 85 Sodertalje, Sweden | 1. Budesonide and Felodipine USP | ||||||
| 39 | 24/07/2008 | FF | Renewal | FF-126 31/12/2008 | M/S AstraZeneca Pharma India Ltd., Avishkar, P.B No. 2483, Off Bellary Road, Hebbai, Bangalore-560024 | M/S. AstraZenenca Operations, Bulk Production, Sweden, AstraZeneca Sverige AB,S-151 85 Sodertalje, Sweden | 1. Metoprolol Succinate Controlled Release Tablet, 2. Symbicort Turbuhaler | ||||||
| 40 | 31/07/2008 | FF | Fresh | FF-75 31/12/2008 | M/S Baxter (India) Pvt. Ltd., 2nd Floor, Tower C, Building 8, DLF Cyber City, DLF Phase, Gurgaon-122002, Plot No.- 70,A-26, Rama Road Indusatrial Area, New Delhi-110015 | M/S. Fenwal Inc., 3 Corporate Drive, Lake Zurich lllinois, 60047 U.S.A | 1. Triple Optipac with CPD & ADSOL, Anticoagulant Citrate Phosphate Dextrose Solution USP (CPD) and ADSOL, 2. Qualdruple Optipac with CPD & ADSOL, Anticoagulant Citrate Phosphate Dextrose Solution USP (CPD) and ADSOL, 3. CPD-SAG-M Optipure RC, 450 ml, Quadruple Blood Pack, 4. CPD-SAG-M Optipure RC, 450 ml Quadruple Blood Pack with integrated filter fro red cells, 5. CPD-SAG-M Optipure RC, 450 ml, Quadruple Blood Pack unit with integrated filter for red cell leucodepletion, for collection of 450 ml blood, 6. CPD-SAG-M Quadruple Blood Collection system with integrated filter for whole Blood, 7. Single Blood Pack unit 450 ml with Anticoagulant Citrate Phosphate DExtrose Adenine Solution EP(CPDA-1), Single, 8. Double Blood Pack unit 450 ml with Anticoagulant Citrate Phosphate Dextrose Adenine Solution EP(CPDA-1), Double, 9. Triple blood Pack unit 450ml with Anticoahulant Citrate Phosphate Dextrose Adenine Soultion EP (CPDA-1), Triple, 10. Triple Blood Pack Unit with Cpd & SAG-M | ||||||
| 41 | 31/07/2008 | FF | Fresh | FF-77 31/12/2008 | M/S Baxter (India) Pvt. Ltd., 2nd Floor, Tower C, Building 8, DLF Cyber City, DLF Phase, Gurgaon-122002, Plot No.- 70,A-26, Rama Road Indusatrial Area, New Delhi-110015 | M/S. Fenwal Inc., 3 Corporate Drive, Lake Zurich lllinois, 60047 U.S.A | 1Anticoagulant Citrate Phosphate Dextrose Solution USP (CPD) Blood Pack Unit; Transfer Pack Container with ADSOL Red Cell Preservation Solution Triple, 2. Anticoagulant Citrate Phosphate Dextrose Adenine Solution USP (C.P.D.A.-1) Blood Pack Unit, Double, 3. Anticoagulant Citrate Phosphate Dextrose Adenine Solution USP (C.P.D.A.-1) Blood Pack Unit,Triple, 4.Anticoagulant Citrate Phosphate Dextrose Adenine Solution USP (C.P.D.A.-1) Blood Pack Unit; Single 350ml, 5. Quadruple Blood Pack Unit, 450 ml, with Citrate Phosphate Dextrose Solution USP (CPD) and ADSOL Red Cell Preservation Solution. | ||||||
| 42 | 31/07/2008 | BD | Renewal | BD-18 31/12/2008 | M/S Esschem (Pvt.) Ltd., 19th Floor, Centre-1, World Trade Centre, Cuffe Parade, Mumbai-400005 | M/S. Sifavitor S.p.a., via Livelli, 1-26852 Casaletto Lodigiano, Fairzione Mairano (LO), Italy | 1. Amiloride Hydrochloride Bp/Usp, 2 . Betahistine Dihydrochloride-In-House, 3.Betaxolol Hydrochloride USP, 4. Clidinium Bromide Ph. Eur.,5. Ipratropium Bromide Ph.Eur., 5. Ipratropium Bromide Ph. Eur., 6. Ketotifen Fumarate Ph. Eur., 7. Loperamide Hydrochloride BP/USP, 8.Mefloquine Hydrochloride BP/Ph.Eur., 9. Sodium Cromoglycate BP/Ph. Eur., 10. Bupropione Hydrochloride, 11. Ciclopiriox Olamine Hydrochloride BP/USP/Ph. Eur., 13. Ottilonium Bromide | ||||||
| 43 | 31/07/2008 | BD | Renewal | BD-162 31/03/2009 | M/S Ethachem, 107, marine chambers, 11 new marine lines, mumbai-400020 | M/S Zhejiang jiuzhou pharmaceutical co. ltd., waisha road 99, jiaojiang district , Taizhou city, zhejiang province, china | 1. Gliclazide BP/USP | ||||||
| 44 | 31/07/2008 | FF | Fresh | M/S GlaxoSmithkline Asia Pvt. Ltd., Dlf Plaza Tower, Dlf City Phase-I, Gurgaon-122002 | M/S ALZA Ireland ltd., Cahir Road, Cashel, Co. Tipperary, Ireland | 1. Nicotine Transdermal System (Patches) 36 mg (Delivers 7 mg over 24 hours), 78 mg (Dellivers 14 mg over 24 hours) and 114 mg (Delivers 21 mg over 24 hours) | |||||||
| 45 | 31/07/2008 | FF | Fresh | M/S GlaxoSmithkline Asia Pvt. Ltd., Dlf Plaza Tower, Dlf City Phase-I, Gurgaon-122002 | M/s Catalent UK Packaging Ltd., Sedge Close, Headway, Great Oakley, Corby, Northants, NN 18 8HS, UK | 1. Nicotine Transdermal System (Patches) 36 mg (Delivers 7 mg over 24 hours), 78 mg (Dellivers 14 mg over 24 hours) and 114 mg (Delivers 21 mg over 24 hours) | |||||||
| 46 | 31/07/2008 | FF | Fresh | M/S GlaxoSmithkline Asia Pvt. Ltd., Dlf Plaza Tower, Dlf City Phase-I, Gurgaon-122002 | M/s Catalent UK Packaging Ltd., Sedge Close, Headway, Great Oakley, Corby, Northants, NN 18 8HS, UK | 1. Nicotine Transdermal System (Patches) 36 mg (Delivers 7 mg over 24 hours), 78 mg (Dellivers 14 mg over 24 hours) and 114 mg (Delivers 21 mg over 24 hours) | |||||||
| 47 | 31/07/2008 | FF | Endorsement | FF-107 31/12/2008 | M/S Sanofi-Synthelabo (India) Ltd., 54/A Sir Mathuradas Vasanji Road, Andheri(East), Mumbai-400093 | M/S Sanofi Winthrop Industrie, 1 Rue de la Vierge, Ambares et Lagrave, 33565, Carbon Blanc, Cedex, France | 1. Plavix 300mg(Clopidogrel hydrogen sulphate equivalent to 300mg clopidogrel) | ||||||
| 48 | 31/07/2008 | FF | Endorsement | FF-230 31/12/2009 | M/S Alcon Laboratories Pvt. Ltd., Unit No: 502, Tower "D", 5th Floor, RMZ Infinity, Benniganahalli, Old Madras Road, Bangalore-560016 | M/S S.A. Alcon-Couvreur n.v. Rijksweg 14, 2870 Puurs, Belgium | 1. Celoftal® (2% Hydroxypropyl Methyulcellulose),Ophthalmic Viscosurgical Device | ||||||
| 49 | 31/07/2008 | FF | Fresh | M/S GlaxoSmithkline Asia Pvt. Ltd., Dlf Plaza Tower, Dlf City Phase-I, Gurgaon-122002 | M/S ALZA Corporation 700 Eubanks Drive vacaville CA 95688 USA | 1. Nicotine Transdermal System (Patches) 36 mg (Delivers 7 mg over 24 hours), 78 mg (Dellivers 14 mg over 24 hours) and 114 mg (Delivers 21 mg over 24 hours) | |||||||
| 50 | 31/07/2008 | BD | Fresh | M/S.Nayyar Medicine co. A-29, 3rd Floor, Sanjay Nagar, Mangolapur Kalan, Delhi-110085 | M/S. Zhejiang Xiang Pharmaceutical Co. Ltd., No. 5 Chuancheng South Road, Chengguan, Xianju, Taizhou, Zhejiang | 1. Betamethasone (EP/BP) | |||||||
| 55 | FF | Renewal | 6-4/FF/88/02/DC (PT-1) | FF-84 31/12/2008 | 1. Seretide Evohaler [Salmeterol (as Xinafoate) 25 meg +Fluticasone Propionate 50meg/125 meg]., 2. Imuran {Azathioprine 50mg Tablet], 3. Relenza [Zanamivir Rotadisk 5mg per blister] |
| APPLICATION RECEIVED FOR REGISTRATION TO IMPORT DRUGS DURING YEAR 2007-08 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| MONTH OF JUNE 2008 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S. NO. | Date of Submission | Application Concerned (BD/FF) | Nature of Application (Fresh, Endorsement, Renewal) | RC No. & Date of Expiry | Name and address of Indian agent | Name and address of manufacturing site to be registered | Name of Drugs | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 1 | 15/6/2008 | FF | Endorsement | FF-130 28/02/2009 | M/S Allergan India Pvt. Ltd, First Floor, Silver Jubliee Block, Unity Building complex, Mission Road 3rd Cross, Bangalore,560027 | M/S allergan sales, USA | 1.Cyclosporine, 0.5 mg/ml | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 2 | 16/6/2008 | FF | Fresh | FF-100 31/12/2008 | M/S Baxter (India) Pvt. Ltd.,Head ofice ,2nd Floor, Tower C., Building 8,DLF Cyber City, Dlf Phase II, Gurgaon-122002 & Plot no.-70, A-26, Rama Road,Industrial Area, New Delhi-110015 | M/S Fenwal Inc., 3 Corporate Drive, Lake Zurich 1 llionois,60047 U.S.A having factory premises at Baxter Heralthcare Corporation U.S. Highway 221 North Marion North Carolina 28752 U.S.A | 1. Anticoagulant Citrate Dextrose Solution USP Formula A (ACD-A) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 3 | 19/6/2008 | BD | Renewal | BD-572 31/1/2009 | M/S Ethachem, 107, Marine Chambers, 11 New Marine Lines, Mumbai- 400020 | M/S Huadong Medicine Co. Ltd., No. 700 Shixiang Road, Hangzhou-310011, china | 1. Acarbose | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 4 | 19/6/2008 | BD | Fresh | M/S Emcure Pharmaceuticals Ltd. Emcure house, T-184, M.I.D.C, Bhosari, Pune-411026 | M/S Prizer Inc. 235 East 42nd Street New Yark-10017-5755(USA) having factory premises at Prizer Health AB Mariefredsvagen37 SE- 64541 Strangnas Sweden | 1. Dalteparin Sodium Bp | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 5 | 19/6/2008 | BD | Fresh | M/S Aquatic Remedies Pvt. Ltd., 218-219 Kailash Plaza Vallabhbaug Lane, Ghatkoper[E], Mumbai-400075 | Deyang Sinozyme Pharmaceutical Co. Ltd., 7She, Kangying Village, Xiaohan Town, Guanghan City, Sichuan Province, China | 1. Pancreatin ,2. Pepsin, 3. Trypsin-Chymotrypsin | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 6 | 19/6/2008 | FF | Renewal+ 1-fresh App. | FF-365 28/02/2009 | M/S Glaxo Smith Kline Pharmaceuticals Ltd., Dr. Annie Besant Road, Mumba-400030 | M/S Glaxo Smith Kline Manufacturing S.P.A. Strada Provinciale Asolana, 90, 43056 San Polo Di Torrile, Parma, Italy | 1. Tracrium Injection( Atracurium Besylate Injection), 2. Zovirsax I.V. for Infusion( Atraclovir Intravenous Infusion- 250mg Freeze Dried Powder), 3. Hycamtin (Topotecan Hydrocholoride for Injection-equivalent to 1 mg & 4mg Topotecan per vial) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 7 | 19/6/2008 | BD | Endorsement | M/S Anantco Enterprises Pvt. Ltd., 194, Arvind Chambers, Gauri Studio Compound, Western Express Highway, Andheri[E], Mumbai-400069 | M/S Zhuhai United Laboratories Co. Ltd, Sanzao Science & Technology Garden, National Hi-tech Zone, Zhuhai, Ghuhai, Guangdong, P.R. China. 0086-0756-7766777 | 1. Ampicillin Sodium & Sulbactam Soudium USp | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 8 | 19/6/2008 | BD | Fresh | M/S Pfizer Ltd. Pfizer Cente, 5, Patal Estate, off SV Road, Jogeswari (West), Mumbai-400102 | Pharmacia & Upjohn Co. 7000Portage Road, Kalamazoo, Michigan | 1. Phenytoin USP | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 9 | 19/6/2008 | BD | Fresh | M/S Anzen Exports 55/3D, Ballygunge Circular Raod, Kolkata-700019 | M/S VUAB Pharma a.s., Vltavska 53,252 63 Roztoky, Czech Republic | 1. Nystatin BP/USP/EP | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 10 | 19/6/2008 | BD | Renewal | BD-533 31/5/2008 | M/S Signet Chemical Coeporation Pvt. Ltd. B/305, Neelam Centre, Hind Cycle Road, Worli,Mumbai-400030 | M/S Roquette Freres, 62136 Lestrem, France | 1.Dextrose Monohydrate USP/NF,EP,BP | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 11 | 19/6/2008 | FF | Renewal | FF-88 | M/S Boehringer Ingelheim India Pt. Ltd., 1st Floor, Alexandra, St. Sebastian Road, Bandra (West), Mumbai | M/S Boehringer Ingelheim Pharma GmbH & Co.. Kg, Birkendorfer Str. 65, 88397 Biberach an der Riss, Germany | 1.Aggrenox® 200/25 mg modified release capsules(Containing Dipyridamole 200 mg+ Acetylsalicylic acid 25 mg) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 12 | 19/6/2008 | FF | Fresh | M/S M.S.D. Pharmaceuticals Pvt. Ltd., Gala NO. 1 A, Building No. J-3, Arihant Corporation, Koper Village, Bhiwandi, Maharashtra-421302 | M/S solay Pharmaceuticals GmbH. Neustadt Works, Justus-Non-Liebig, Straβe 33, 31535, Neustadt a. Rbge,Germany having factory premises at Justus-Von-Liebig, Str.33,D-31535, Neustadt a. Rbg, Germany | 1. Pancreatin IP,2. Pancreatin Minimicrospheres, 3. Pancreatin Minimicrospheres 25000,4. Pancreatin /Minimicrospheres 40000 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 13 | 19/6/2008 | BD | Renewal | BD-145 28/02/2009 | M/S Solvay Pharam India Ltd. Suraj Prakash, 54/A Sir M V Road, Andheri(E) Prabhadevi Mumbai-400025 | M/S Frosst Iberica S.A., Via Complutense, 140, 28805 Alcala de Henares, Masdrid, Spain | 1. Fixed Dose combintion of Sitagliptin Phosphate and Metformin HCI Tablets( 50mg/500mg and 50mg/1000mg) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 14 | 19/6/2008 | FF | Renewal | FF-221 | M/S Sandor Medicaids Pvt. Ltd, Lateef Plaza, Road No. 4, Banjara Hills, Hyderabad-500034 | M/S Chinoin Pharmaceutical and Chemical Works Pvt. Co. Ltd.,To utca I-5, Budapest, H-1045, Hungary | 1. Carboprost Tromethamine USP, 2. Dinoprostone BP, 3. Drotaverine Hyderochloride | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 15 | 19/6/2008 | BD | Renewal | BD-135 28/02/2009 | M/S Aventis Pharma Limited, 54-A Sir M V Road, Andheri, Mumbai-400093 | M/S Genzyme Corporation, Genzyme Biosurgery Divison, 112 Pleasant View Terace, Ridgefield, New Jersey 07657, USA. | 1. Synvisc-One | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 16 | 19/6/2008 | FF | Renewal | M/S Fresenius Medical Care India Pvt. Ltd., 411-412(4th Floor), Vishwasadan Tower, District Centre, Janak Puri New Delhi. | M/S Sanofi-Aventis Deutschland GmbH, Industriepark Hoechst, 65926, Frankfurt am Main, Germany | 1. Ciclopiroxolamine, 2. Fexofenadine Hydrochloride,3. Furosemide, 4. Glibenclamide, 5. Glimepiride, 6. Metamizole Sodium, 7. Pentoxyfyline, 8. Ramipril | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 17 | 19/6/2008 | BD | Endorsement | BD-606 25/05/2009 | M/S Eastern Chemnicals, Laxmi Apartment, Bhagwanji Mavji Bldg., 54/A, J.P. Road, Near YWCA Hostel, Andheri [w], Mumbai-400058 | M/s Fresenius Medical Care Deutschland GmbH, St. Wendel Plant, Frankfurter Str. 6-8, 66606 St Wendel, Germany | 1. Capd/Dpca, 2. Capd/Dpca, 3. Capd/Dpca, 4. Peritoneal Diaylsis Solutions | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 18 | 20/6/2008 | BD | Renewal | BD-29 31/12/2008 | M/S Solvay Pharam India Ltd. Suraj Prakash, 86 Shankar Ghanekar Marg, Prabhadevi Mumbai-400025 | M/S Maizhou Baida Pharmaceutical Co. Ltd., No.14, Industrial East Road, Xianju, Zhejiang-317300, China | 1. Megestrol Acetate BP, 2. Methylprednisolone USP | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 19 | 23/6/2008 | FF | Renewal | FF-42 31/12/2008 | M/S Astra Zeneca Pharma India Limited, Avishkar, P.B No 2483, Off Bellary Road Hebbal, Bangalore- 560024, | M/s Astra Zeneca S.P.A., Viale Dell 'Industria, 3 Caponago (MI) 20040, Italy | 1. Propofol 1% Injection 20ml Ampoules and 50 ml Vials( Diprivan) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 20 | 23/6/2008 | FF | Renewal | FF-30 31/12/2008 | M/S Astra Zeneca Pharma India Limited, Avishkar, P.B No 2483, Off Bellary Road Hebbal, Bangalore- 560024, | M/S Astra Zeneca UK Limited, Silk Road Business Park, Macclesfield , Cheshire, SK10 2NA, United Kingdom. | 1. Meropenem Injection IP 500mg and 1g (Meronem 500mg & 1g), 2. Tamoxifen Tablets IP( Nolvadex 10mg, 3. Goserelin Acetate Injection 3.6 mg and 10.8mg (Zoladex 3.6 mg and Zoladex LA 10.8 mg), 4. Bicalutamide Tablets 150 mg (Casodex 150mg) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 21 | 23/6/2008 | BD | Fresh | M/S Sandor Medicaids Pvt. Ltd, Lateef Plaza, Road No. 4, Banjara Hills, Hyderabad-500034 | M/S Genzyme Ireland Ltd., IDA industrial Park, Old Kilmeadan Road, Waterford,Ireland | 1. Renvela | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 22 | 24/6/2008 | FF | Endorsement | FF-380 31/05/2009 | M/S Bristol-Myers squibb srl, Contrada Fontana Del Ceraso, 03012 Angani, Italy | M/S Bristol Myers Squibb India Pvt. Ltd. At 1st Floor,'A' Block, Shiv Sagar Estate, Dr. Besant Road, Worli, Mumbai-400018 | 1. Paracetamol Solution for Infusion 10mg/ml(Perfalgan™) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 23 | 24/6/2008 | FF | Endorsement | FF-417 30/04/2011 | M/S Reckitt Benckiser India Ltd., 227 Okhla Industiral Estate, Phase-III, New Delhi-11020 | M/S Reckitt Benckiser Healthcare (UK) Ltd., 103-105 Bath Road, Slough, Berkshire, SL 3UH, England | 1. Gaviscon Peppermint Liquid Relief, 100ml Glass Bottles | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 24 | 24/6/2008 | FF | Fresh | M/S Sandor Medicaids Pvt. Ltd., 101 Lateef Plaza, Road No. 4, Banjara Hills, Hyderabad-500034 | M/S Genzyme Corporation ,500 Soldiers Field Road, Allston, MA 02134 USA | 1. cholestagel | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 25 | 24/6/2008 | Fresh | M/S Sandor Medicaids Pvt. Ltd., 101 Lateef Plaza, Road No. 4, Banjara Hills, Hyderabad-500034 | M/S Genzyme Corporation ,500 Soldiers Field Road, Allston, MA 02134 USA & M/S Genzyme Ireland ltd., Industreial Park Old Kilmeadan Road, Waterland, Ireland | 1. Cerezyme 200 U & 400U | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 26 | 24/6/2008 | FF | Fresh | M/S Sandor Medicaids Pvt. Ltd., 101 Lateef Plaza, Road No. 4, Banjara Hills, Hyderabad-500034 | M/S Genzyme Corporation ,500 Soldiers Field Road, Allston, MA 02134 USA | 1. Fabrazyme | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 27 | 25/6/2008 | BD | Renewal | BD-216 28/02/2009 | M/S Esschem (Pvy.) Ltd., 19th Floor, Centre-1, World Trade Centre, Cuffe Parade, Mumbai-400005 | M/S Dipharma Francis S.r.l., Via Origgio, 23 21042 Caronno Pertusella (VA), Italy | 1. Ursodeoxycholic Acid EP, 2. Bendroflmethiazide USP/EP | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 28 | 25/6/2008 | FF | Fresh | M/S M.S.D. Pharmaceuticals Pvt. Ltd., Gala NO. 1 A, Building No. J-3, Arihant Corporation, Koper Village, Bhiwandi, Maharashtra-421302 | M/S Merck, sharp & Dohme, shotton Lane, Cramlington, NorthumberlandNE23 9JU, UK | 1. Montelukast Sodium 10mg film coated tablets, 2. Montelukast Sodium 4mg and 5mg chewable tablets | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 29 | 25/6/2008 | FF | Renewal | FF-363 14/02/2009 | M/S Piramal healthcare Ltd, Nicholas Piramal Tower, Ganpatrao Kadam Marg, Lower Parcel, Mumbai-400013 | M/S Pierre Fabre Medicament 45, place Abel-gance, 92100 boulogne, France having factory premises at M/S Pierre Fabre Medicamen production, Establissement Aquitaine Pharma International Avenue Du Bearn- 64320, Idron, France | 1. Vinorelbine(Navelbine) 10mg/ml(vials of 1 ml and 5ml) Concentrate for solutin for infusion | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 30 | 26/6/2008 | BD | Endorsement | BD-707 28/02/2011 | M/S Pharmacosmos A/S Roervangsvej, DK -4300 Holback, Denmark | M/S Pharmacosmos A/S, Roervangsvej 30, DK- 4300 Holback, Denmark | 1.Dextran 70,000 USP | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 31 | 30/6/2008 | FF | Renewal | FF-80 31/12/2008 | M/S German Pharmaceutical Ltd., No: 63, Palace Road, Vasanthnagar, Bangalore-560052 | M/S Meckel Spenglersan GmbH, Steinfeldweg 13, D-77815, Buhl Baden, Germany | 1. Ginkgo Meckel (Ginkgo Biloba Drops), 2. Spenglersan Colloid-G | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 32 | 19/06/2008 | BD | Renewal | BD-31 31/12/2008 | M/S Sterling Agencies, 66, Commercial Chambers, Yusuf Meheralli Road, Mumbai-400003 | M/S Daiichi Fine Chemical Co.ltd., 530 Chokeiji, Takaoka,Toyama-900-8500, Japan | 1. D-Calcium Panthothenate, 2. Dexpanthenol | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 33 | 24/06/2008 | BD | Renewal | BD-522 30/06/2008 | M/S Archerchem, Unit No. 211 & 212, 2nd Floor, Linkway Estate Premises CHS Ltd., Malad Link Road, Malad [W], Mumbai-400064 | M/S Synbias Pharma Ltd., Prospert Panfilova 15, Donetsk, Ukraine, 83114 having premises at Roza Luksemburg SG 70,Donetsk, Ukraine, 83114 | 1. Doxorubicin Hydrochloride EP, 2. Idarubicin Hydrochloride USP, 3. Epirubicin Hydrochloride EP | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 34 | 20/6/08 | BD | Endorsement | BD-624 31/08/09 | M/s. Arun & Co, 603/B Polaris, Off Marol Maroshi Road, Andheri (E), Mumbai, 400059. | M/s.Institut Rosell Inc., 8480 St-Laurent Bivd. Montreal, Quebec, Canada H2P 2M6. | Lp 299v Bulk Powder | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||