LIST OF BLOOD
PRODUCTS,
REGISTERED IN INDIA
ALONG WITH
THEIR
MANUFACTURING
SITE AND INDIAN
AUTHORIZED
AGENTS DURING THE
YEAR 2007-2009
S.No NAME OF NAME OF VALIDITY PRODUCTS
AUTHORISED AGENT MANUFACTURER
1 M/s. Biogenuix M/s. CSL Bearing 1/07/2008 - 1. ANTI HAEMOPHILIC
Medsystems Pvt. Ltd., GMBH, Germany 30/06/2011 FACTOR VIII (BERIATE P)
New Delhi 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. HEPATITIS B-
IMMUNOGLOBULIN P
BEHRING - EP
5. HUMAN SERUM
ALBUMIN 20 % BEHRING
LOW SALT - EP.
2 M/S RUSHI CORP., M/S GREEN CROSS 02/04/09 - 1.HUMAN SERUM ALBUMIN
Mumbai PHARMA DERIVATIVES 01/04/2012 (ALBUMIN 20%)
CORP., KOREA 2. NORMAL HUMAN
IMMUNOGLOBULIN (I.V.
GLOBULIN S)
3. Anti Hemophilic Factor
VII( Green VII Inj) 250 IU
3 M/S BAXTER INDIA M/S BAXTER AG., 06.01.09 - 1. HUMAN ANTI D (Rho)
PVT. LTD., GURGAON AUSTRIA 05.01.2012 IMMUNOGLOBULIN INJ.
(PARTOBULIN) - E.P.
2. HUMAN ALBUMIN
SOLUTION. 5%, 20%, 25%
EP/IP
3. ANTI INHIBITOR
COAGULANT COMPLEX,
STREAM TREATED (FEIBR
STIM 4)-EP
4. PURIFIED FREEZE – DRIED
HUMAN COAGULATION
FACTOR VIII VIRUS
INACTIVATED (IMMUNATE)-
EP
5. TISSEEL KIT (FIBRIN
SEALANT KIT)
FREEZE DRIED
6. HUMAN COAGULATION
FACTOR IX FREEZE DRIED
(IMMUNNE) -EP
4 M/S MEDISPAN LTD., M/S OCTA PHARMA 1.01.2009- 1. HUMAN ALBUMIN
Chennai. PHARMAZEUTIKA PRO 31.12.2011 SOLUTION 5%, 20%
AUSTRIA (ALBUMED) – EP/IP
2. HUMAN NORMAL
IMMUNOGLOBULIN
(OCTAGAM) – 1g, 2.5g, 5.0g,
10g EP/IP
5 M/S ALPHA DRUGS M/S BIO PRODUCTS 1.01.2009- 1. HUMAN SERUM ALBUMIN
LABORATORY 31.12.2011 -ZENALB 20) – 50ml, 100 ml
U.K 2. HUMAN SERUM ALBUMIN
-ZENALB 4.5) – 50ml, 100 ml,
250 ml & 500 ml
3. NORMAL HUMAN
IMMUNOGLOBULIN I.V.
FREEZE
DRIED POWDER 2.5 g, 5 g
(VIGAM-S) – IP/EP
4. ANTI HEMOPHILIC
FACTOR VIII
250 IU AND 500 IU (DRIED
FACTOR VIII FRACTION,
TYPE
8Y) – IP/EP.
5. ANTI HEMOPHILIC
FACTOR IX
250 IU, 500 IU & 1000 IU
(REPLENINE – VF) – EP
6 M/S SYNERGY M/s. HUMAN 25.11.2008 - 1. HUMAN SERUM ALBUMIN
DIAGNOSTICS PVT. BIOPLAZMA 24.11.2011 20 % - IP / EP 2.
LTD. MANUFACTURING & I.V.GAMMA (HUMAGLOBIN-
TRADING LTD. 5gm, 2.5gm & 0.5gm) - EP
LIABILITY Co. 3. TETANUS
HUNGARY IMMUNOGLOBULIN (TETIG-
500I.U. & 250 I.U.) EP.
7 M/S BAXTER INDIA M/S BAXTER 01.01.2009 - 1. ANTIHEMOPHILIC FACTOR
PVT. LTD., New Delhi HEALTHCARE 31.12.2011 (HUMAN), (HEMOFIL M,
CORPORATION, USA MONOCLONAL PURIFIED) –
USP
2. HUMAN ALBUMIN
SOLUTION . 20%, 25%
(BUMINATE) IP/USP
3. ALBUMIN(HUMAN), USP,
25% SOLUTION
4. FLEXBUMIN ALBUMIN
(HUMAN) USP, SOLUTION
8 M/S SYNERGY DIAG. M/S KAMADA LTD. 1.05.2009- 1. ANTI-D (Rho)
PVT. LTD. ISRAEL 30.04.2012 IMMUNOGLOBULIN I.M
(Kam – Rho – D IM) – EP.
2. ANTI-D (Rho)
IMMUNOGLOBULIN I.M
(Kam – Rho – D I.V.) – EP.
3. ANTI-RABIES
IMMUNOGLOBIN I.M
(KAMRAB)-EP
9 M/S JOHNSON & M/S ORTHOCLINICAL 1.04.2009- 1. Rho GAM ULTRA-
JOHNSON LTD. DIAG. INC., 31.03.2012 FILTERED PLUS 300 mcg
USA (Human anti-D
Immunoglobulin 300 mcg)
2.MICRhoGAM ULTRA-
FILTERED Plus 50 mcg
(HumanAnti-D IMMUNO
GLOBULIN 50 mcg)
10 M/S. PAVIOUR M/s. BIOTEST 01.07.2009- 1. HUMAN NORMAL
PHARMACEUTICALS PHARMA, GMBH, 30.06.2012 IMMUNOGLOBULIN I.V
PVT. LTD., NEW DELHI GERMANY (PENTAGLOBIN) -EP/IP
2. HUMAN NORMAL
IMMUNOGLOBULIN I.V
(INTRATECT)
3. HUMAN ALBUMIN 20%,
5% IP / EP
4. ANTI HEMOPHILIC
FACTOR VIII (FACTOR VIII
SDH) EP
5. HUMAN HEPATITIS B
IMMUNOGLOBULIN
(HEPATECT CP) EP
11 M/s. BHARAT SERUM M/S. GRIFOLS 15.11.2007- HUMAN SERUM ALBUMIN
AND VACCINE LTD., BIOLOGICALS INC., 14.11.2010 (ALBUTEIN) IP 5%, 20%
MUMBAI USA
12 M/s United Biotech M/s. KEDRION S.P.A, 01/12/2009 1. Anti-Hemophilic Factor IX
(P) Ltd., NEW DELHI ITALY - PH. EUR. (AIMAFIX)- 200
31/11/2012 IU/250 IU/500 IU/ 1000 IU
2. Anti-Hemophilic Factor
VIII PH. EUR. (EMOCLOT)-
200 IU/250 IU/500 IU/1000
IU
3. Normal Human
Immunoglobulin Intravenous
PH. EUR./I.P. ( Ig VENA)-
1g/20ml, 2.5g/50ml,
5g/100ml, 10g/200ml
4. Normal Human Serum
Albumin PH. EUR./I.P.
(UMAN ALBUMIN
20g/100ml)- 50ml & 100ml.
5. Human Plasma
Prothrombin Complex
concentrate (factors – II-IX-
X), lyophilized (UMAN
COMPLEX D.I.) - 500 IU
13 M/S. VHB M/S. HUALAN 01.12.08 - HUMAN NORMAL
LIFESCIENCE, MUMBAI BIOLOGICALS 31/05/2010 IMMUNAGLOBULIN (IVIG)
ENGINEERING INC , 5% IP.
CHINA
14 M/s. UNITED BIOTECH M/s. HARDIS SPA S.A., 1.09.2007- 1. ANTI-D (RHO) HUMAN
(P) LTD., NEW DELHI ITALY 31.08.2010 IMMUNOGLOBULIN I.M.
300mcg (IMMUNO RHO) EP
15 M/S. RELIANCE LIFE M/S. TALECRIS 1.09.2008- 1. Plasma protein
SCIENCE PVT. LTD., BIOTHERAPEUTICS 30.08.2011 fractanation powder
MUMBAI INC. , WEST CLAYTON, (HUMAN) 2. Plasma
USA protein fractanation paste
(HUMAN) 3. Fraction IV-4
paste
4. Fraction V-paaste
5. Cryo precipitate paste
6. Albumin paste
7. Albumin Powder
M/S. BHARAT SERUM 1. Immune Globulin
& VACCINE LTD. Intravenous (Human) 10%
MUMBAI Caprylate/Chromatography
Purified, USP- 10ml,
25ml,50ml, 100ml &200ml
(GAMUNEX®) 2.
Plasmanate 5% 250 ml
16 M/S. RELIANCE LIFE M/S. TALECRIS 17.05.2009- 1. Fraction V-paaste
SCIENCE PVT. LTD., BIOTHERAPEUTICS 16.05.2012 2. Cryo precipitate
MUMBAI INC. , NEWYORK, USA
17 M/S. EL SHADDAI M/S. HARBIN SEQUEL 1.03.2009- 1. HUMAN HEPATITIS B
BIOLOGICALS LTD. BIOENGINEERING 29.02.2012 IMMUNIGLOBULIN (HBIG) EP
CHENNAI PHARMA CENTRIC CO. 2. HUMAN
LTD. , CHINA IMMUNOGLOBULIN FOR I.V.
INJC. (IVIG) EP
3. HUMAN FIBRONOGEN
4. HUMAN TETANUS
IMMUNOGLOBULIN
18 M/S. PAVIOUR M/S. CANGENE 16.02.2009- WIN Rho SDF Rho(D) Anti-D
PHARMACEUTICALS CORPORATION , 15.02.2012 IMMUNOGLOBULIN
PVT. LTD., NEW DELHI CANADA (HUMAN)
19 M/S. MEDISPAN LTD. , M/S. OCTAPHARMA , 12.09.2007- RHESONATIVE 625 IU
CHENNAI SWEDEN 11.09.2010 SOLUTION-HUMAN ANTI-D
IMMUNOGLOBULIN
20 M/s. BHARAT SERUM M/S. SHANGHAI 1.06.2009- 1. HUMAN
AND VACCINE LTD., INSTT. OF 31.05.2012 IMMUNOGLOBULIN (PH 4)
MUMBAI BIOLOGICALS FOR I.V. INJECTION
PRODUCT, CHINA
21 M/S SYNERGY DIAG. M/S. SHANDONG 1.01.2008- 1. HEPATITIS B
PVT. LTD. MISSILE BIOLOGICALS 31.12.2010 IMMUNIGLOBULIN I.M. 200
PRODCUTS PVT. LTD. , IU-BP
CHINA 2. HUMAN
IMMUNOGLOBULIN (PH 4)
FOR I.V. INJECTION 1.25
gm/2.5 gm/5.0gm BP
22 M/S BAXTER INDIA M/S BAXTER 29.11.07- FLOSEAL HEMOSTATIC
PVT. LTD., New Delhi HEALTHCARE 30.10.2010 MATRIX
CORPORATION, USA
23 M/S. RELIANCE M/S. GUIYANG 30.07.2008- 1. HUMAN
LIFESCIENCES , NAVI OIANFENG 29.07.2011 IMMUNOGLOBULIN ( pH
MUMBAI BIOLOGICALS 4)FOR INTRAVENOUS
PRODUCTS CO. LTD. INJECTION BP, 2.5g/vial of
5% solution 50 ml & 100 ml.
2. HUMAN
IMMUNOGLOBULIN ( pH
4)FOR INTRAVENOUS
INJECTION BP, 5g/vial of 5%
solution 100 ml.
24 M/s. BHARAT SERUM M/S. GUIYANG 29.12.2008- 1.HUMAN
AND VACCINE LTD., OIANFENG 28.12.2011 IMMUNOGLOBULIN (10%
MUMBAI BIOLOGICALS 0.3G/VIAL)
PRODUCTS CO. LTD. 2. HUMAN RABIES
IMMUNOGLOBULIN (200 IU/
VIAL)
25 M/S CLARIS M/s. CSL Bearing 1.07.2009- 1. HUMAN
LIFESCIENCES LTD. GMBH, Germay 30.06.2012 IMMUNOGLOBULIN (PH 4)
FOR I.V. INJECTION
(NORGLOBIN 5%)
26 M/s. BHARAT SERUM M/S. GREEN CROSS 1.06.2009- 1. HUMAN TETANUS
AND VACCINE LTD., CORPORATION , 31.05.2012 IMMUNOGLOBULIN BULK
MUMBAI KOREA POWDER-GCC
2. HUMAN I.V
IMMUNOGLOBULIN BULK