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Last updated on : 08/08/2018
You are here:  HOME | Approval | CT APPROVAL 2016-2018


CT APPROVAL 2016-2018


CT NOC 2018







M/s. Akums Drugs and Pharmaceuticals Ltd.

New Drugs

2 Verapamil ER M/s Dr. C. Padmapriyadarsini New Drug
3 Pirfenidone M/s. Cipla Ltd. New Drug
4 Anagliptin M/s. MSN laboratories Pvt Ltd New Drug
5 Februric (Febuxostat) M/s. Ajanta Pharma Ltd. New Drug
6 M/s. Eisai  Pharmaceuticals Pvt Ltd. New Drug
7 Sofosbuvir / Velpatasvir FDC M/s Mylan Laboratories Ltd New Drug
8 M/s AstraZeneca GCT
9 YLB113 M/s Lupin GCT
10 M/s J&J GCT
11 MB02 (Bevacizumab Biosimilar Drug) M/s Kendle GCT
12 Emicizumab M/s Roche GCT
13 NexoBrid M/s Apothecaries GCT
14 Baricitinib M/s Eli Lilly GCT
15 QAW039 M/s Novartis GCT
16 Torsemide Extended Release M/s Syngene GCT
17 Baricitinib M/s Eli Lilly GCT
18 AMG 334 M/s Novartis GCT
19 SCY 078 M/s Syngene GCT
20 Daprodustat M/s PPD GCT
21 Regorafenib M/s. Bayer Pharmaceuticals Pvt Ltd New Drug
22 M/s Ajanta Pharma SND
23 Spironolactone cream 5% M/s AlkemLaboratories  SND
24 Ormeloxifene tablet 120mg M/s HLL Lifecare SND
25 Everolimus tablet 0.25/0.5/0.75/1mg & dispersible tablet 0.1/0.25mg M/s Novartis Healthcare SND
26 Tacrolimus ointment 0.1% M/s Intas Pharma SND
27 M/s Amneal GCT
28 M/s AstraZeneca GCT
29 ASN100 M/s Pharm-Olam GCT
30 Pimodivir M/s Quintiles GCT
31 Fitusiran M/s PPD GCT
32 Pimodivir M/s Quintiles GCT
33 CLS-TA M/s Excel Life Sciences GCT
34 Darunavir Tablet 800mg M/s Cipla Ltd. SND
35 Amgen GCT
36 Semaglutide 2.4 mg Novo Nordisk GCT
37 Semaglutide 2.4 mg Novo Nordisk GCT
38 Filgotinib KlinEra GCT
39 Sotagliflozin Sanofi-Synthelabo GCT
40 Efpeglenatide Sanofi-Synthelabo GCT
41 Durvalumab AstraZeneca GCT
42 M/s. Cadila Healthcare Ltd New Drugs
43 Delamanid Dr. Arun Kowale New Drugs
44 Azelnidipine tab 16 mg M/s. Ajanta Pharma Ltd New Drugs
45 Enzalutamide M/s. Astellas Pharma India Pvt Ltd New Drugs
46 M/s Ajanta Pharma Ltd. SND
47 Calcipotriol/AKVANO 50 µg/g cutaneous solution M/s Cadila Pharmaceuticals Ltd. SND
48 Azilsartan Medoxomil + Chlorthalidone (40mg+25mg,40mg+12.5mg 40mg+6.25mg) Tablets (Phase-III). M/s MSN Laboratories Private Limited FDC
49 Alcaftadine 0.25% w/v + Ketoroloc Tromethamine 0.4% w/v Eye drops    (Phase-III). M/s Ajanta Pharma Limited FDC
50 M/s Ajanta Pharma Limited FDC
51 Metoprolol Succinate ER + Chlorthalidone + Telmisartan (50mg+12.5mg+40mg, 25mg+12.5mg+40mg) film coated tablets (Phase-III). M/s Ajanta Pharma Limited FDC
52 Pregabalin IP (As Prolonged Release) 75mg + Etoricoxib IP 60mg uncoated bilayered tablets (Phase-III). M/s Sun Pharma Laboratories Limited FDC
53 TRC041266 M/s. Torrent pharmaceuticals ltd NEW DRUGS
54 M/s. Mylan lab New Drugs
55 Dalfampridine M/s. Sun pharma lab ltd New Drugs
56 Dr. Chanchal Kumar New Drygs

CT NOC 2017

S.No Drug Firm Category
1 Fimasartan Tablet
M/s. Ajanta Pharma
New Drugs
2 Ripasudil Hydrochloride Eye drop M/s. Ajanta Pharma New Drugs
3 Lorcaserin Hydrochloride M/s. Dr Reddy’s Laboratories Ltd New Drugs
4 Daclatasvir M/s. Hetero Labs Ltd New Drugs
5 CDRI New Drugs
6 Ulipristal Acetate 5 mg M/s. Ajanta Pharma New Drugs
7 K0706 M/s. Sun Pharma New Drugs
8 ZYZN1 M/s. Cadila Healthcare Ltd New Drugs
9 ZYTP1 M/s. Cadila Healthcare Ltd New Drugs
10 Compound97/98 M/s CDRI New Drugs
11 Etodolac Injection 400mg/2mL M/s Ipca laboratories Ltd SND
12 Heparin Sodium 1000IU/mL non aqueous topical solution M/s Troikaa Pharmaceuticals Ltds SND
13 Diclofenac rectal solution with applicator (Diclofenac sodium 50 mg/squirt) M/s Lincoln Pharmaceuticals ltd SND
14 Tramadol infusion 0.1 % w/v  M/s Akums Drugs & Pharmaceuticals  SND
15 Ethylesters of iodized fatty acids of poppy seed oil solution for injection
(Lipidol Ultra Fluid 10 ml)
M/s Dispo Surgicals
16 Anagliptin M/s. Ajanta Pharma Ltd. New Drug
17 Apremilast M/s. Ajanta Pharma Ltd New Drug
18 M/s. Ajanta Pharma New Drug
19 Evogliptin M/s. Alkem laboratories ltd New Drug
20 FDC of Mupirocin calcium, Neomycin sulfate & HT61 HCL M/s. Cadila Pharmaceuticals Ltd New Drug
21 M/s. Natco Pharma Ltd. New Drug
22 M/s. Wockhardt Ltd. New Drug
23 M/s. Glenmark New Drug
24 Remogliflozin Etabonate (CT/ND/37/2017) M/s. Glenmark New Drug
25 M/s. Spectrum Oncology Pvt  Ltd New Drug
26 Endoxifen M/s. Intas Pharmaceutical Ltd   New Drug
27 Orla CPL 2009-0031 M/s. Cadila Pharmaceutical Ltd. New Drug
28 ZYKR1    M/s. Cadila Healthcare Ltd. New Drug
29 Ibu tiJide Fumarate injec tio n (O.lm g/ml) M/s. Zuventus Pharma ltd.   New Drug
30 Aprernilast    M/s. Dr. Reddy’s laboratories Ltd.    New Drug
31 Azilsartan plus Chlorthalidone M/s. Hetero Labs Ltd. New Drug
32 Ulipristal acetate   M/s. Synokem Pharma ltd.    New Drug
33 Phase III CT with Pantaprazole dual-release gastro-resistant tablets 80 mg M/s Sun Pharma Laboratories Limited SND
34 Azilsartan Medoxomil 40 mg and Chlorthalidone 12.5 mg tablets M/s. Ajanta pharma New Drug
35 Carbetocin RTS IV  M/s. Ferring Pharmaceutical Pvt Ltd  New Drug
36 Glycopyrronium +Formoterol Fumarate Dihydrate dry powder for inhalation (Phase III) M/s. Glenmark Pharmaceuticals Ltd. FDC
37 Multibic potassium-free, 2mmol/L & 4mmol/L Potassium solution haemofiltration (Phase III) M/s. Fresenius Medical Care India Pvt.  Ltd. FDC
38 Alfuzosin HCl ER +Tadalafil tablets (Phase III) M/s. Sun Pharma Laboratories Ltd. FDC
39 Glycopyrronium (As Glycopyrrolate USP) +Formoterol Fumarate Dihydrate capsule (Phase III) M/s. Cipla Ltd. FDC
40 Tenofovir Disoproxil Fumarate IP + Lamivudine IP + Efavirenz IP(Film coated tablets) (Phase IV)  M/s. Mylan Laboratories Ltd.    FDC FDC
41 Perindopril Erbumin BP + Indapamide IP tablet (Phase IV) M/s. Serdia Pharmaceuticals (I) Pvt. Ltd. FDC
42 Sildenafil + Dapoxetine (Film coated tablets) (Phase III) M/s. Ajanta Pharma Ltd.    FDC
43 Benzoyl Peroxide(2.5 %/5%), Polysiloxanes and Zinc oxide M/s. Dr Reddy’Laboratories Ltd New Drug
44 M/s. Pharmazz India Pvt Ltd. New Drug
45 PMZ-1620 (CT/ND/66/2017) M//s. Pharmazz India Pvt Ltd. New Drug
46 Levomilnacipran ER  M/s. MSN Labs New Drug
47 M/s. Glenmark Pharmaceuticals Ltd. FDC
48 Spironolactone IP + Chlorthalidone IP uncoated tablets (Phase III) M/s. IPCA Laboratories Ltd. FDC
49 Glycopyrronium (as Glycopyrrolate USP) + Formoterol Fumarate Dihydrate IP eq. to Formoterol Fumarate Capsules for Inhalation (Phase III) M/s. Restech Pharmaceuticals FDC
50 Oxaceprol + Paracetamol film coated tablet (Phase III) M/s. Synokem Pharmaceuticals Ltd. FDC
51 Perindopril Erbumin BP + Indapamide IP + Amlodipine Besilate IP eq. to Amlodipine tablets (Phase III) M/s. Serdia Pharmaceuticals (I) Pvt. Ltd. FDC
52 Apremilast M/s. Hetero Labs Ltd. New Drug
53 Roche GCT
54 CliniRx GCT
55 I C Bio GCT
57 Cliantha GCT
58 Novo Nordisk GCT
59 Sofosbuvir Klinera GCT
60 Bilastine M/s. Hetero Labs Ltd. New Drug
61 M/s. Novo Nordisk GCT
62 Anastrozole & Letrozole M/s. Eli Lilly GCT
63 Insulin Degludec M/s. Novo Nordisk GCT
64 M/s. Pfizer GCT
65 M/s. Cipla Biotec GCT
66 M/s. Pfizer GCT
67 M/s. CliniRx GCT
68 M/s. Boehringer GCT
69 M/s. Parexel GCT
70 M/s. Sanofi GCT
71 M/s. Covance GCT
72 M/s. Cliantha GCT
73 M/s.Novartis GCT
74 M/s.Novartis GCT
75 M/s. Roche GCT
76 M/s. Roche GCT
77 M/s. Boehringer GCT
78 M/s. RA Chem Pharma GCT
79 M/s. Spectrum GCT
80 M/s. Quintiles GCT
81 M/s. Novartis GCT
82 M/s. Novo Nordisk GCT
83 M/s. PPD GCT
84 M/s. PPD GCT
85 M/s. Johnson & Johnson GCT
86 M/s. Excel Life GCT
87 M/s. Klinera GCT
88 Filgotinib M/s. Klinera GCT
89 PBL1427 M/s. Panacea Biotech Ltd. New Drug
90 M/s. Glenmark pharmaceuticals Ltd. New Drug
91 M/s. Themis Medicare Ltd. New Drug
92 M/s. Eli Lilly GCT
93 LY900014 (Insulin Lispro) M/s. Eli Lilly GCT
94 Empagliflozin M/s. Quintiles GCT
95 Empagliflozin M/s. Quintiles GCT
96 RSV M/s. Kendle GCT
97 Abemaciclib M/s. Eli Lilly GCT
98 QAW039 M/s. Novartis GCT
99 Ixekizumab M/s. Eli Lilly GCT
100 Apixaban M/s. BMS GCT
101 Alpelisib M/s. Novartis GCT
102 LCZ696 M/s. Novartis GCT
103 PEGylated factor M/s. Baxalta GCT
104 Ticagrlor M/s. Astra Zeneca GCT
105 Atezolizumab(ANTI-PD-L1Antibody) M/s. Roche GCT
106 Ruxolitinib M/s. Novartis GCT
107 Deferasirox Formulation(Granules) M/s. Novartis GCT
108 M/s. Astra Zeneca GCT
109 QMF149 M/s. Novartis GCT
110 Ribociclib M/s. Novartis GCT
111 Dulaglutide M/s. Eli Lilly GCT
112 MOD-4023 M/s. JSS GCT
113 Dapagliflozin M/s. Astra Zeneca GCT
114 M/s. Quintiles GCT
115 ANF-Rho M/s. Amneal GCT
116 SPI-2012 M/s. Spectrum GCT
117 Atezolizumab M/s. Roche GCT
118 Eltrombopag M/s. Novartis GCT
119 LNP1892 M/s. Lupin GCT GCT
120 Canagliflozin M/s. Novo Nordisk GCT
121 Ribociclib M/s. Novartis GCT
122 M/s. Quintiles GCT
123 Masitinib M/s. Apothecaries GCT
124 Selonsertib M/s. Klinera GCT
125 Selonsertib M/s. Klinera GCT
126 Filgotinib M/s. Klinera GCT
127 Filgotinib M/s. Klinera GCT
128 Filgotinib M/s. Klinera GCT
129 Filgotinib M/s. Klinera GCT
130 Tenofovir Alafenamide M/s. Klinera GCT
131 LNP3794 M/s. Lupin GCT
132 Filgotinib M/s. Klinera GCT
133 Secukinumab M/s. Novartis GCT
134 Povidone -Iodine M/s. JSS GCT
135 Arimoclomol M/s.Covance India Pharmaceuticals Service Pvt ltd. New Drug
136 M/s Sun Pharma SND
137 Clobetasol Propionate topical foam 0.05%  w/w M/s Torrent  SND
138 Hydroxychloroquine sulphate 300mg tablet M/s IPCA SND
139 Rivastigmine 27 mg 15cm2 transdermal patch  M/s Novartis SND
140 Tacrolimus lipid suspension for Ophthalmic Drops-0.005% w/v M/s Intas SND
141 M/s IPCA SND
142 Ormeloxifene tablet (30mg/60mg/90mg) M/s HLL SND
143 Nonoxynol-9 (1.0971g) vaginal contraceptive sponges M/s Virchow SND
144 Saroglitazar 4mg tablet M/s Cadila SND
145 TRC150094 M/s.Torrent  Pharmaceuticals ltd. New Drug
146 CA-170 M/s. Aurigene Discovery Technologies Ltd. New Drug
147 GRC 27864 M/s.Glenmark  Pharmaceuticals ltd. New Drug
148 M/s. Synokem Pharmaceuticals Ltd FDC
149 Olmesartan Medoxomil IP 20mg/40mg + Chlorothalidone IP 12.5mg + Cilnidipine 10mg film coated tablets (Phase-IV). M/s. Sun Pharma Laboratories Ltd. FDC FDC
150 M/s. Encube Ethicals Pvt.Ltd., FDC
151 Azilsartan Medoxomil Potassium eq. to Azilsartan Medoxomil 40mg/40mg + Cilnidipine 5mg/10mg film coated tablet (Phase-III). M/s. Ajanta Pharma. Ltd. FDC
152 Glycopyrrolate USP Glycopyrronium 12.5mcg +Formoterol Fumarate Dihydrate IP 12mcg +Fluticasone Propionate IP 250mcg dry powder inhaler capsules (Phase III). M/s. Glenmark Pharmaceuticals Ltd. FDC
153 Morpholino anti sense M/s.Muscular Dystrophy Patients’ Welfare Society New Drug
154 M/s. Novartis GCT
155 Bempedoic Acid (ETC-1002) M/s. Quintiles GCT
156 Povidone-Iodine Nail Solution M/s. JSS GCT
157 Dapagliflozin M/s. PRA GCT
158 Canagliflozin M/s. J&J GCT
159 Denosumab M/s. Amgen GCT
160 Selinexor M/s. Excel Life Sciences GCT
161 CLS-TA M/s. Excel Life Sciences GCT
162 Lorlatinib (PF-06463922) M/s. Pfizer GCT
163 Atezolizumab M/s. Roche GCT
164 SB11 M/s. Quintiles GCT
165 Dinutuximab and Irinotecan M/s. Novotech GCT
166 LUBT010 M/s. Lupin GCT
167 ABP 798 M/s. PRA GCT
168 Nintedanib M/s. Boehringer GCT
169 Selinexor (KPT-330) M/s. Excel Life Sciences GCT
170 ribociclib M/s. Novartis GCT
171 Ataluren M/s. Medpace GCT
172 BIO-11006 M/s. Cliantha GCT
173 Ivabradine Prolonged Release Tablets 10mg/15mg M/s Abott Healthcare Laboratories Ltd. SND
174 Heparin Sodium Topical (1000 IU/ml) solution M/s Troikaa Pharmaceuticals Ltd. SND
176 Sofosbuvir 400 mg tablets M/s Cadila Healthcare Ltd. SND
177 Sofosbuvir 400 mg tablets M/s Mylan Laboratories  Ltd. SND
178 Tadalafil + Dapoxetine (20mg +60mg, 20mg+30mg, 10mg+30mg) film coated tablets (Phase-III). M/s. Ajanta Pharma Ltd. FDC
179 M/s. Amgen Technology Pvt Ltd New Drug
180 Sodium Copper Chlorophyllin M/s. Lambda therapeutic Research ltd New Drug
181 M/s. AstraZeneca Pharma (I) Ltd New Drug


CT NOC 2016

M/s Sun Pharmaceutical Industries Ltd.
M/s Pfizer
M/s Pfizer
M/s Boehringer
M/s Novartis
M/s Novo Nordisk
M/s Novartis
M/s Kendle
9 Cisplatin Dr. Hemant Raj.E New Drugs
10 Oxaliplatin Dr. Hemant Raj. E New Drugs
11 Ulipristal Acetate M/s Cipla Limited New Drugs
12 Eribulin Mesylate M/s Eisai Pharmaceuticals New Drugs
13 Anagliptin M/s Intas Pharmaceuticals New Drugs
14 Mirabegron M/s Hetero New Drugs
15 ZYTPLA1 M/s Cadila Healthcare New Drugs
16 Rotigotine Transdermal Patch M/s UCB India Pvt. Ltd. New Drugs
17 Sofosbuvir (Phase IV) M/s Hetero New Drugs
18 Slidenfil Citrate Orally Disintegrating Strips 25/50mg M/s NU Therapeutics Pvt. Ltd. SND
19 Pentosen polysulfate sodium capsule 100mg M/s Cliantha Research Limited SND
20 Lurasidone (Phase III) M/s. Hetero Labs Limited New Drugs
21 Ulipristal acetate M/s. BDR Pharmaceuticals International Pvt Ltd. New Drugs
22 Prucalopride M/s. Hetero Labs Limited New Drugs
23 Aprimilast M/s. Glenmark Pharmaceuticals Ltd New Drugs
24 Dr. Shivaprasad GCT
25 Masitinib Maya Clinicals GCT
26 Semaglutide Novo Nordisk GCT
27 Clindamycin Amneal GCT
28 RLX030 Novartis GCT
29 Sofosbuvir Klinera GCT
30 MDR-TB Drugs National Institute for Research in TB GCT
31 B1695502 Boehringer GCT
32 Insulin degludec Novo Nordisk GCT
33 Lopinavir/Ritonavir BJMC Pune (Dr. Sandhya Khadse) GCT
34 BIASP-30 Novo Nordisk GCT
35 Clinirx GCT
36 Insulin Aspart Novo Nordisk GCT
37 QMF149 Novartis GCT
38 Indacaterol Novartis GCT
39 Ticagrelor I process GCT
40 Azelnidipine M/s Ajanta Pharma Ltd New Drugs
41 L0731-Na  M/s. Sun Pharma Advance Research Company Ltd. New Drugs
42 PMZ-1620 M/s. Pharmazz India Pvt. Ltd. New Drugs
43 Efonidipine M/s Ajanta Pharma Ltd New Drugs
44 Azelnidipine M/s Hetro Labs New Drugs
46 MEDI4736 AstraZeneca GCT
47 Ceritinib Novartis GCT
48 MEDI4736 AstraZeneca GCT
49 Rivaroxaban AIIMS GCT
50 Trimcinolone Acetonide Excel Life Sciences GCT
51 Degludec/Liraglutide Novo Nordisk GCT
52 Ranibizumab Novartis GCT
53 GS-5745
54 Semaglutide Novo Nordisk GCT
56 Liraglutide Novo Nordisk GCT
57 NNC0195-0092 Novo Nordisk GCT
58 BCD-055 Biocad GCT
59 Clotrimazole Troche/Logenges USP 10mg M/s Thinq Pharma CRO Ltd SND
60 Prednisolone Delayed Release Tablets 5mg M/s Cadila Healthcare Limited. SND
61 Ginkgo biloba extract tablets 120mg M/s Dr.Willmar Schwabe India Pvt. Ltd SND
62 Rivastigmine Transdermal Patch (one-half of 4.6mg/24hr patch) Accutest Research Laboratories (I), Pvt. Ltd. SND
63 Sevelamer Hydrochloride Tablets 800mg M/s Cadila Pharmaceuticals Ltd SND
64 Efonidipine Hydrochloride Ethanolate M/s. Ajanta Pharma New Drugs
65 Atosiban M/s. Zuventus Healthcare Ltd New Drugs
66 Sofosbuvir + Ledipasvir M/s. Hetero Labs Ltd. New Drugs
67 Iguratimod tablets M/s. Ajanta Pharma New Drug
68 M/s. Ajanta Pharma New Drug
69 Levocetrizine tablets M/s. Ajanta Pharma New Drug
70 Alogliptin M/s. Takeda Pharmaceutical India Pvt Ltd New Drug
71 Bepotastine tablets M/s. Ajanta Pharma New Drug
72 PMZ 2010 M/s. Pharmazz India Pvt Ltd New Drug
73 Nepafenac Ophthalmic Suspension 0.3% w/v        M/s Ajanta Pharma Ltd SND
74 Ivermectin Cream 1.0% w/w         M/s Ajanta Pharma Ltd SND
75 Acebrophylline SR + Montelukast Tablet M/s. Sun Pharma Laboratories Ltd. FDC
76 Chlordiazepoxide + Trifluoperazine HCl (Film coated tablet) M/s. Synokem Pharmaceuticals FDC
77 Formoterol Fumarate Dihydrate IP + Glycopyrronium (Dry powder for inhalation) M/s. Glenmark Pharmaceuticals Ltd FDC
78 Indacaterol Maleate + Glycopyrronium Bromide (Inhalation powder, hard capsules) M/s. Novartis Healthcare Pvt. Ltd. FDC
79 Metoprolol Succinate ER + Telmisartan + Chlorthalidone tablet M/s. Sun Pharma Laboratories Ltd. FDC
80 Amitriptyline Hydrochloride + Pregabalin tablet M/s. Sun Pharma Laboratories Ltd. FDC
81 Repaglinide + Voglibose tablet M/s. Torrent Pharmaceuticals Ltd. FDC
82 Tramadol + Dicyclomine + Acetaminophen tablet M/s. Wockhardt Ltd FDC
83 Vildagliptin + Metformin Hydrochloride tablet M/s. Novartis Healthcare Pvt. Ltd FDC
84 Bilastine tablet M/s. Ajanta Pharma Ltd. New Drug
85 Remifentanil and Fentanyl M/s. Themis Medicare Ltd. New Drug



Start date: 24/03/2016

End date: 26/12/2066 

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