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      LIST OF CRITICAL DIAGNOSTIC KITS, BLOOD PRODUCTS,AND MEDICAL DEVICES REGISTERED IN INDIA ALONG WITH THEIR MANUFACTURING SITE AND INDIAN AUTHORIZED AGENTS FOR IMPORT TILL SEPTEMBER, 2005

S.NO. NAME OF AUTHORISED AGENT NAME OF MANUFACTURER PRODUCTS  

31.   

M/s. RANBAXY LABORATORIES LIMITED, NEW DELHI

M/s. BIOKIT S.A., SPAIN

1.      BIO ELISA HIV ½ TEST KIT

2.      BIO ELISA HBsAg TEST KIT

3.      BIO ELISA HCV TEST KIT

4.   HBsAg ELISA KIT (BIOELISA HBsAg COLOUR)

 

      32.

M/s. RANBAXY DIAGNOSTICS, NEW DELHI

M/s. ANI LABS SYSTEMS OY, FINLAND

1.      HIV-EIA

2.      HBsAg EIA PLUS

      33.

M/s. LILAC MEDICARE , MUMBAI

M/s. EQUIPAR S.R.L., ITALY

1.      HIV 1+ 0 /  2 Ab SCREENING

2.      HCV Ab ELISA

3.      HBsAg ONE STEP ELISA

     34.

M/s. CAMBINDIA BIOTECH KITS (PVT.) LTD., HARAYANA

M/s. TRINITY BIOTECH PLC., IRELAND

 

1.      HIV ½ RAPID LATEX ASSAY (CAPILLUS HIV ½ )

2.      HIV ½ RAPID IMMUNOCHROMATOGRAPHIC ASSAY (UNIGOLD HIV ½ )

3.      HIV ½ RAPID ELISA ASSAY (SEROCARD HIV ½ )

4.      HBsAg RAPID IMMUNOCHROMATOGRAPHIC (UNIGOLD HBsAg)

5.      HCV RAPID ELISA ASSAY (SEROCARD HCV)

6.      HIV ½ ELISA KIT (RECOMBIGEN HIV ½ MICROPLATE EIA)

      35.

M/s. SAXSONS BIOTECH PVT. LTD., DELHI

M/s. CIS BIO INTERNATIONAL, FRANCE

1.      PULMOCIS KIT

2.      NANOCIS KIT

      36.

M/s. ERZA BROTHERS, MUMBAI

M/s. DOMINION BIOLOGICALS, CANADA

BLOOD GROUPING SERA

      37.

M/s. ERZA BROTHERS, MUMBAI

M/s. DOMINION BIOLOGICALS, CANADA

BLOOD GROUPING SERA

      38.

M/s. JOHNSON & JOHNSON LTD., MUMBAI

M/s. CHIRON CORPORATION, USA

1.      CHIRON RIBA HIV-1/HIV-2 STRIP IMMUNOBLOT ASSAY (SIA)

2.       CHIRON RIBA HCV STRIP IMMUNOBLOT ASSAY (SIA)

      39.

M/s. SUYOG DIAGNOSTICS PVT. LTD., NEW DELHI

M/s. DIA SORIN S.R.L., ITALY

HBsAg ELISA KIT (ETI-MAK-4)

      40.

M/s. GENETECH DIAGNOSTIC PVT. LTD., NEW DELHI

M/s. DIGENE CORPORATION, USA

HYBRID CAPTURE II HBV DNA TEST

      41.

M/s. GLAXOSMITHKLINE PHARMACEUTICAL LTD., MUMBAI

M/s. SEROLOGICALS LTD., UK

BLOOD GROUPING SERA

42.

 M/s. ABBOTT HEALTHCARE PVT. LTD., MUMBAI M/s. ABBOTT LABORATORIES, USA HBsAg EIA KIT (AUSZYME MONOCLONAL

43.

 M/s. APPLICA BIO-DIAGNOSTIC, BANGALORE M/s. DIAGAST LABORATORIES, FRANCE BLOOD GROUPING SERA

44.

 M/s. ROCHE DIAGNOSTIC INDIA PVT. LTD., MUMBAI M/s. ROCHE MOLECULAR SYSTEMS INC.,
  1. COBAS AMPLICOR HBV MONITOR KIT
  2. COBAS AMPLISCREEN HBV KIT
  3. COBAS TAGMAN HIV-1 KIT
  4. COBAS TAGMAN HBV KIT
          COBAS TAGMAN HCV KIT

 

    45.

M/s. VEDA LABS, FRANCE

M/s. MONOZYMES INDIA LTD.,

HBsAg DIPSTICK

HBsAg DIPSTICK (HEP-CHECK-1 DIPSTICK) RAPID TEST

 

46.

M/s SHANTHA BROTECH LTD.

 M/s AVLCANNA MEDICAL CENTRE, MOSCOW, RUSSIA

  1. ANTI-HIV 1+2 EIA AVICENNA

ANTI-HCV-EIA-AVICENNA

 

47.

M/s. BAYER DIAGNOSITIC INDIA LTD., BARODA

M/s. BAYER HEALTHCARE, USA

  1. VERSANT HIV-1 RNA 3.0 RNA (bDNA)

  2. TRUGENE HIV-1 GENOTYPING KIT

  3. VERSANT HCV GENOTYPING ASSAY

  4. VERSANT HCV RNA QUALITATIVE ASSAY

  5. VERSANT HCV RNA 3.0 ASSAY (bDNA)

VERSANT HBV DNA 3.0 ASSAY (SDNA)

 

 

LIST OF BLOOD PRODUCTS

 

S.NO.

NAME OF AUTHORISED AGENT

NAME OF MANUFACTURER

PRODUCTS

1.       

M/S UNITED BIOTECH PVT. LTD.

NEW DELHI

M/S FINNISH RED CROSS, BLOOD TRANSFUSION SERVICE,

FINLAND

1. HUMAN ALBUMIN SOLUTION 20% (ALBUMIN SPR 200 mg/ml) EP/IP

2.  HUMAN NORMAL IMMUNOGLOBULIN FOR INTRAVENOUS ADMINISTRATION LYOPHLISED (VENOGAMME) – 0.6g, 3g, 6g, 9g EP/I.P.

3. ANTI-HEAMOPHILIC FACTOR IX (BEMOFIL) – 500 I V &
1000 I V - EP

 

2.       

M/S LIFE MEDICARE AND BIOTECH PVT. LTD.

NEW DELHI

M/S SCOTTISH NATIONAL BLOOD TRANSFUSION SERVICE

U.K.

1. HUMAN ALBUMIN SOLUTION 20% (ALBA 20%) EP/IP

 

3.       

M/S BAXTER INDIA PVT. LTD.

NEW DELHI

M/S BAXTER HEALTHCARE CORPORATION

CALIFORNIA

1. FACTOR IX COMPLEX, HEAT TREATED (PROPLEX T) - USP

 

2. ANTIHEMOPHILIC FACTOR (HUMAN), (HEMOFIL M, MONOCLONAL PURIFIED) – USP

 

3. HUMAN ALBUMIN SOLN. 20%, 25% BUMIRATE IP/USP

 

4.       

M/S BAXTER INDIA PVT. LTD.

NEW DELHI

M/S BAXTER AG

AUSTRIA

1. HUMAN ANTI D (Rho) IMMUNOGLOBULIN INJ. (PARTOBULIN) - EP

 

2. HUMAN ALBUMIN SOLN. 5%, 20%, 25% EP/IP

 

3. HUMAN NORMAL IMMUNOGLOBULIN FOR I.V. USE (ENDOBULIN) S/D FREEZE DRIED VIRUS INTRAVATED – IP/EP

 

4. ANTI INHIBITOR CO-AGULENT COMPLEX, STREAM EREATED (FEIBR STIMU)

 

5. PURIFIED FREEZE – DRIED HUMAN COAGULATION FACTOR VIII VIRUS INACTIVATED (IMMUNATE) EP

 

6. TISSEEL KIT (FIBURISCRLAND)

KIT FREEZE DRIED

 

7. IMMUNE FACTOR IX

 

5.       

M/S MEDISPAN LTD.

CHENNAI

M/S OCTA PHARMA PHARMAZEUTIKA PRO    

AUSTRIA

1. HUMAN ALBUMIN SOLUTION 5%, 20% (ALBUMED) – EP/IP

 

2. HUMAN NORMAL IMMUNOGLOBULIN (OCTAGAM) – 1g, 2.5g, 5.0g, 10g EP/IP

 

6.       

M/S CRITICARE PHARMA

MUMBAI

IMPORTER :- M/S CADILA HEALTHCARE LTD., AHEMDABAD.

M/S AVENTIS BEHRING GMBH

GERMANY

1. ANTI HAEMOPHILIC FACTOR VIII  (BERIATE P)  250 IU, 500 IU,  1000 IU - EP


2. HUMAN NORMAL IMMUNOGLOBULIN INJECTION (I M) (BERIGLOBIN P) – IP/EP

 

3. ANTI HAEMOPHILIC FACTOR IX (BERININ P) 300 IU, 600 IU, 1200 IU - EP


4. HUMAN RABIES IMMUNOGLOBULIN
(BERIRAB P) - EP


5. HUMAN NORMAL IMMUNOGLOBULIN I.V. (GAMMA-VENIN P) – IP/EP


6. ANTI HAEMOPHILIC FACTOR VIII, LYOPHILISED (HAEMATE P) 250 IU, 500 IU,  1000 IU - EP


7. HEPATITIS
B-IMMUNOGLOBULIN P
BEHRING  - EP


8. HUMAN SERUM ALBUMIN 20 % BEHRING LOW SALT - EP


9. KYBERNIN P 500 IU,
1000 IU - EP


10. HUMAN ANTI D (RHO) IMMUNOGLOBULIN
(MATERGAM P) - EP


11. HUMAN TETENUS IMMUNOGLOBULIN
(TETAGAM P) - EP


12. HUMAN INTRAVENOUS 7
S – IMMUNOGLOBULIN (VENIMMUN N) - EP

 

7.       

M/S ALPHA DRUGS

NEW DELHI

M/S BIO PRODUCTS LABORATORY

U.K

1. HUMAN SERUM ALBUMIN 20 %, 4.5 % (ZENALB 20, 4.5) – IP/EP


2. NORMAL HUMAN IMMUNOGLOBULIN I.V. FREEZE DRIED POWDER 2.5 g, 5 g (VIGAM-S) – IP/EP


3. ANTI HEMOPHILIC FACTOR VIII 250 IU AND 500 IU (DRIED FACTOR VIII FRACTION, TYPE 8Y) – IP/EP.


4. ANTI HEMOPHILIC FACTOR IX 250 IU, 500 IU & 1000 IU (REPLENINE – VF) – EP

5. HUMAN ANTI-D RHO IMMUNOGLOBULIN I.M. BP

6. HUMAN TETANUS IMMUNOGLOBULIN I.M. BP

7. HUMAN RABIES IMMUNOGLOBULIN I.M. BP

8.       

M/S RUCHI CORP.

MUMBAI

M/S GREEN CROSS PHARMA DERIVATIVES CORP.,

KOREA

1. HUMAN NORMAL IMMUNOGLOBULIN I.V. (VERGLOB) – IP/EP


2. HEPATITIS B IMMUNE GLOBULIN HUMAN I.M.
(HEPABIG INJ.) – EP

 

9.       

M/S CLARIS LIFESCIENCES LTD.

AHMEDABAD

 

 

 

M/S ZLB BIO PLASMA AG,

SWITZERLAND

1. HUMAN NORMAL ALBUMIN 20 % (HUMIN 20) – EP/IP


2. HUMAN NORMAL IMMUNOGLOBULIN I.V. (SANDOGLOBULIN) 1gm, 3 gm, 6 gm, 12 gm – IP/EP

 

10.   

M/S V.H.BHAGAT & CO.

MUMBAI

M/S SICHUAN YUANDA SHUYANG PHARMACEUTICAL CO. LTD.

CHINA

 

1.NORMAL HUMAN IMMUNOGLOBULIN I.V. – I.P.

2.HUMAN SERUM ALBUMIN I.P.

11.   

M/S JOHNSON & JOHNSON LTD.

MUMBAI

M/S ORTHOCLINICAL DIAG. INC.,

USA

1. Rho (D) IMMUNE GLOBULIN (HUMAN) (RhoGAM ULTRAFILTERED) – USP


2. Rho (D) IMMUNE GLOBULIN (HUMAN) MICRhoGAM ULTRAFILTERED – USP

12.   

M/S BHARAT SERUMS & VACCINES LTD.

MUMBAI

M/S HUMAN SERUMS PRODUCTION & MEDICINE MFG. CO. LTD.

HUNGARY

1. HUMAN NORMAL IMMUNOGLOBULIN I.V. (HUMAGLOBIN-CMV IgG INJ. FREEZE DRIED) - EP


2. HUMAN SERUM ALBUMIN 20 % - IP / EP


3. HUMAN NORMAL IMMUNOGLOBULIN (HUMAN GAMMA-GLOBULIN) 16%


4. HUMAN TETANUS IMMUNOGLOBULIN

 

13.   

M/S SYNERGY DIAG. PVT. LTD.

THANE

M/S KAMADA LTD.

ISRAEL

1. ANTI-D (Rho) IMMUNOGLOBULIN I.M (Kam – Rho – D IM) – EP

 

14.   

M/S BHARAT SERUMS & VACCINES LTD.

MUMBAI

M/S ALPHA THERAPEUTIC CORP.

USA

1. HUMAN SERUM ALBUMIN 5 %, 20 %, 25 % (ALBUTEIN) – IP/USP

 

15.   

-DO-

M/s. GREEN CROSS PLASMA DERIVATIVES, KOREA

1.      HUMAN TETANUS IMMUNOGLOBULIN (BULK)

2.      HUMAN IMMUNE SERUM GLOBULIN POWDER (BULK)

16.   

M/s. BHARAT SERUMS & VACCINES LTD., MUMBAI

M/S. HARDIS SPA., ITALY

1.      HUMAN ANTI-D IMMUNOGLOBULIN

2.      HUMAN TETANUS IMMUNOGLOBULIN

17.   

M/S. PAVIOUR PHARMACEUTICALS PVT. LTD., NEW DELHI

M/s. BIOTEST GMBH, GERMANY

1.      HUMAN NORMAL IMMUNOGLOBULIN (PENTAGLOBIN)

2.      HUMAN NORMAL IMMUNOGLOBULIN 2.V EP / IP (INTRAGLOBIN F)

3.      HUMAN NORMAL IMMUNOGLOBULIN (INTRAGLOBIN CP) EP / IP

4.      HUMAN ALBUMIN 20%, 5% IP / EP

5.      ANTI HEMOPHILIC FACTOR VIII (FACTOR VIII SDH) EP

6.      HUMAN HEPATITIS B IMMUNOGLOBULIN (HEPATECT CP) EP

7.      ANTI-HUMAN T LYMPHOCYTE RABBIT GLOBULIN EP

18.   

M/s. BHARAT SERUM AND VACCINE LTD., MUMBAI

M/s. HEMATALOG LTD., RUSSIA

1.      IMMUNOGLOBULIN G ANTI RHESUS RHO (O) MONOCLONAL)

2.      HUMAN (RHESOCLONE CONCENTRATED )

      19.

M/s. HEMOPHILIA FEDERATION (INDIA), NEW DELHI

M/s. KEDRION SPA, ITALY

1.      ANTI-HEMOPHILIC FACTOR VIII (EMOCLOT D.I.) E.P. 250IU, 500 IU, 1000IU

2.      ANTI-HEMOPHILIC FACTOR IX (AIMAFIX D.I.) E.P. 200 IU & 500 IU

3.      HUMAN NORMAL IMMUNOGLOBULIN I.V. (Ig VENA) EP / IP 1g, 2.5g, 5g, 10g

4.      HUMAN SERUM ALBUMIN (UMAN ALBUMIN) IP/EP 20%

     20.

M/s. SHREE KRISHNA KESHAV LABORATORIES LTD., AHMEDABAD

M/s. INSTITUTO GRIFILS SA, SPAIN

1.      HUMAN ALBUMIN

2.      HUMAN TETANUS IMMUNOGLOBULIN

21. M/S UNITED BOITECH(P) LTD: NEW DELHI M/S HARDIS SPA S,A, ITALY

1.   ANTI-D (RHO) HUMAN IMMUNOGLOBULIN I.M. 300mcg (IMMUNO RHO)

2    NORMAL HUMAN        IMMUNOGLOBULIN 1g, 2.5g 10g I.V. (ISIVEN V.I.)

 

22. M/s. SHREE KRISHNA KESHAV LABORATORIES LTD., AHMEDABAD M/s. INSTITUTE GRIFOLS SA, SPAIN
  1. HUMAN ALBUMIN
  2. HUMAN TETANUS IMMUNOGLOBULIN
  3. NORMAL HUMAN IMMUNOGLOBULIN

ANTI TRENOPLOTIC FUNCTION VIII

 

23. M/s. CLARIS LIFE SCIENCES LTD., AHMEDABAD M/s. HUALAN BIOLOGICAL ENGINEERING, CHINA HUMAN NORMAL IMMUNOGLOBULIN FOR IV NORAGROBIN
24. M/s. UNITED BIOTECH (P) LTD., NEW DELHI M/s. HARDIS S.P.A., ITALY
  1. ANTI-D (Rho) HUMAN IMMUNOGLOBULIN I.M. 300 mcg (IMMUNO RHO)

NORMAL HUMAN IMMUNOGLOBULIN 1g, 2.5g, 10g (ISIVEN V.I.)

 

25. M/s. BHARAT SERUMS & VACCINES LTD., MUMBAI M/s. GRIFOLS, USA HUMAN SERUM ALBUMIN
26. MAY M/.S N.W. OVERSEAS, PANIPAT M/S. DIAGNOSTIC GRIFOLS, S.A. BARULONR, SPAIN BLOOD GROUPING SERE.
27. HEPARIM SODIUM Ph-Eur M/S. BHARAT BIOTECH, HYDERABAD M/S. NANJING HIGH & NEW TECHNOLOGY, CHINA
28. ENOXAPARIN SODIUM M/S. BHARAT BIOTECH, HYDERABAD M/S. NANJING HIGH & NEW TECHNOLOGY, CHINA
29. SIMVASTATIN USP M/S. ESSCHEM PRIVATE LIMITED, MUMBAI M/S. ZHEJIANG JIANGBEI PHARMACEUTICAL CO. LIMITED, CHINA
30. L-PROLINE M/S. SAI QUEST PRIVATE LIMITED, HYDERABAD M/S. GUANGDONG ZHAOQING, CHINA
31. INOSINE M/S. SAI QUEST PRIVATE LIMITED, HYDERABAD M/S. GUANGDONG ZHAOQING, CHINA
32. MANNITOL BP/USP/EP M/S. SIGNET CHEMICAL CORPORATION, MUMBAI M/S. ROQETTE FRERES, FRANCE
33. SODIUM RABEPRASDE DONEPEZIL HYDROCHLORIDE,
 AUGUST		 M/S. EISAI PHARMACEUTICALS INDIA PRIVATE LIMITED, MUMBAI M/S. EISAI CO. LIMITED, JAPAN
34. M/S. HEMOJENINUS PRIVATE LIMITED, BANGALORE, 
SEPTEMBER		 M/S. GEW-PROBE INCORPORATE 10210 GENETIC CIRCLE DRIVE, SANDIEGO CA, 92121 PROCLEIX ULTRIO ASSAY.

 

 

MEDICAL DEVICES

 

S. NO.

NAME OF THE FIRM

PRODUCT

AUTHORIZED AGENT IN INDIA

7.

M/s. Karex Industria SDN BHD PTD, Malaysia  

Latex Male Condom

M/S. Polar  Pharma India Limited, Orissa

      8.

M/s. JMS Singapore Pvt. Ltd., Singapore

1.      Infusion Sets

       2.Transfusion Sets

M/S. Allwin Lifecare, Mumbai

    9. M/s. MAHAVIR ENTERPRISES, KOLKATA M/s. DONGKUK TECHNO RUBBER INDUSTRIES, MALAYSIA MALE LATEX CONDOM (Finish)
10. Becton Dicinson S.A. CTRA. Mequineza s/n 22520, Fraga (Huesca) Spain 1.Solomed Two pieces breakable plunger syringes as per BIS standard

2.Solomed Two pieces breakable plunger syringes with

needles as per BIS Standard

 

 M/s. Becton Dickinson India Pvt. Ltd
11 JMS SINGAPORE PVT. LTD. SINGAPORE 1.Blood Collection bags with anticoagulant CPDA-1

2.Blood Collection bags with anticoagulant CPD-SAGM

 

 Allwin Lifecare, Mumbai
12 //// feb Baxter Healthcare Corporation, San German, Puerto Rico, USA 1.Closed System Apheresis Kit (for use with CS 3000 plus Blood Cell Separator)

2. Open System Apheresis Kit (for use with CS 3000 plus Blood Cell S

 

 Baxter India Limited, Gurgaon
13 M/ NIPRO CORPORATION, JAPAN S.
  1. STERILE DISPOSABLE HYPODERMIC SYRINGES SINGLE USE ONLY, AS PER BIS STANDARD
  2. STERILE DISPOSABLE HYPODERMIC SURINGES WITH NEEDLES FOR SINGLE USE ONLY, AS PER BIS STANDARD.
 M/S. VAISHNAVI SURICALS, CHENNAI
14 MAY M/S. NIPRO CORPORATION, THAILAND
  1. STERILE DISPOSABLE HYPODERMIC SYRINGES FOR SINGLE USE ONLY, AS PER BIS STANDARD.
  2. STERILE DISPOSABLE HYPODERMIC SYRINGES WITH NEEDLES FOR SINGLE USE ONLY, AS PER BIS STANDARD.
  3. STERILE DISPOSABLE HYPODERMIC NEEDLES FOR SINGLE USE ONLY, AS PER BIS STANDARD.
 M/S. VAISHNAVI SURICALS, CHENNAI
15 MS/. BAXTER HEALTHCARE CORPORATION, USA ALYX RED KIT FOR USE WITH ALYX AUTOMATED COMPONENT COLLECTION SYSTEM  
16  M/S. PLEASURE LATEX PRODUCTS SDN, MALAYSIA MALE LATEX CONDOMS-FINISHED  
17  M/S. BAXTER INDIA PRIVATE LIMITED, TRIPLE BLOOD PACK UNIT 450ML WITH CPDA-1, ANTI COAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE SOLUTION USP (CPDA-1), TRIPLE. M/S. BAXTER INDIA PRIVATE LIMITED, MUMBAI