Status of marketing authorization of bacterial, Combination, Conjugate & Polysaccharide vaccine for the year Jan 2008- Dec 2010.

S.No. / Name of Firm / Date / Name of Molecule Approved / Indication / Dosage Form & Strength
  1. 18
/ Wyeth Ltd.,RBC,Mahindra Towers,4th Floor (A-wing),Dr.G.M ,Bhosale Road,Worli,Mumbai-400 018 / Form 45 (122 A) permission issued vide permission No. Imp/6199/05. dated 29th Feb, 2008 / Pneumococcal -7-valent conjugated vaccine
Source-Wyeth pharmaceutical Inc. Philadelphia, PA 19101 / Fr active immunization of Infants and toddlers against otitis media caused by the serotypes of this vaccine / Injection (IM)
  1. 19
/ Human Biological Institute (division of M/s Indian Immunological ltd.,),Rakhshapuram,Gachibowli,Hyderabad -500 019 / Form 46 (122 B) permission issued Vide permission No. MF-334/08 dated 24th March,2008 / Diphtheria-Tetanus Vaccine (adsorbed)(DAG) IP / For active immunization against Diptheria and Tetanus in healthy children between 4 to 6 years of age / Liquid
Injectable
  1. 20
/ Bharat biotech India Pvt. Ltd.,Genome Valley,Shameerpet (M),Hyderabad-500 078 / Form 46 (122 B) permission issued vide permission No MF-515/08 dated 12th May 2008 / Combination of Diptheria+tetanus +Pertussis +hepatitis +Haemophilus Influenzae type b Vaccine +Haemophilus Type B vaccine / For active immunization against diphtheria, tetanus ,pertussis ,hepatitis B & Haemophilus Influenzae Type B / Injection (IM)
  1. 21
/ Sanofi Pasteur Pvt. Ltd., D-2 ,Fourth Floor,Southern part , DDA,Commecial centre ,Saket,New-Delhi-110 017 / Form 45 (122 A) permission issued Vide permission No. Import -877/08 dated 12th August, 2008 / Combination of tetanus toxoid +Diptheria Toxoid component pertussis vaccine
Source-Sanofi Pasteur ltd., 1755 steeles AvenueWest, Toronto Ontario, Canada M2R 3t4 / For active immunization against Tetanus ,diphtheria and Pertussis / Injection (IM)
  1. 22
/ Biomed Ltd.,C-96 ,Site No1,Bulandsahar Road,Industrial Area,Ghaziabad ,U.Ps / Form 46 (122 B) permission issued vide permission No.MF-7/09 dated 12th Jan,2009 / Meningococcal polysaccharide vaccine / For active immunization against Neisseria memingitidis Group A &C / Injection (Intramuscular and subcutaneous)
  1. 23
/ Biovet Ltd.,Life Science (P) Ltd., Sy.NO 16,Ekarajapura,Hasigala Post ,8th Km,Siddlagatta Road,Hosakote,Bangalore-562 114 / Form - 46 (122 B) permission issued vide permission No.MF-298/09 dated 24th May 2009 / Vi Polysaccharide Typhoid vaccine / For active immunization against typhoid fever for adults and children older than two years of age. / Injection (IM)
  1. 24
/ Bharat biotech International Ltd., Genome valley ,Shameerpet (M),Hyderabad-500 078 / Form 46 (122 B) permission issued vide permission No. MF-515/08dated 1st Sep,2009 / Liquid pentavalent vaccine containing DTwP+Hep B (rDNA)+Hib PRP TT conjugate in prefilled syringe (PFS)Comvac-5 / For active immunization against diphtheria,tetanus ,pertussis ,hepatitis b & Haemophilus influnenzae type b / Injection (IM)
  1. 25
/ Biol.E.Ltd.,18/1 and 3,Azamabad,Hyderabad-500 020 / Form -46 (122-B) permission issued vide permission No. MF-800 dated 23rd Sep, 2009 / Reconstituted pentavalent vaccine(diphtheria,tetanus,Pertussis (whole cell),Hepatitis b (r DNA) and hib conjugate vaccine (adsorbed) / For active immunization against Diptheria,Pertussis ,Tetanus,Hepatitis B, Haemophilus Influenza type b infections / Injection (IM)
  1. 26
/ PanEra Biotec Pvt Ltd.,Ambala Chandigarh Highway,Lalru-140 501,Punjab / Form 46 (122 -B) permission issued vide permission No. Bulk -283/09 dated 19th March 2009 / Reduced diphtheria and acellular pertussis vaccine (Adsorbed), DTwP (bulk ) concentrate / NIL / NIL
Panacea Biotec Ltd., ,B-1 Extn.A-27,MCIE,MAthira Road,New-Delhi -110 044 / Form 46 (122 -B) permission issued vide permission No. MF-282/09 dated 19th March 2009 / Diphtheria ,Tetanus and whole cell pertussis vaccine / For the primary immunization of Infants ,at or above the age of 6 weeks ,and of children through 6 years of age against Diphtheria ,Tetanus and whooping cough / Injection (IM)
  1. 27
/ Biovel Life Science,Sy No 16,Ekarajapura ,Hasigala Post,8th Km,Siddlagatta Road,Hosakote,Bangalore-562 114 / Form 46 (122 -B) permission issued vide permission No. MF-299/09 dated 24th March , 2009 / Haemophilus Influenza type b (Hib) conjugate vaccine / For active immunization against Haemophilius Infuenzae Type b infection in children of the age group of 6 weeks to 5 years. / Injection (IM)
  1. 28
/ Shantha Biotech,Survey No: 272,Athvelli Village,Medchal Mandal,Ranga Reddy District -501 401 ,Hyderabad (A.P) / Form 46 (122 -B) permission issued vide permission No. MF-176/09 dated 24th Feb , 2009 / Killed Bivalent (O1 &O139) oral cholera vaccine / For active immunization against Vibrio Cholera / Liquid vaccine for Oral Administration
  1. 30
/ Wyeth Ltd.,RBC,Mahindra Towers,4th Floor (A-wing),Dr.G.M ,Bhosale Road,Worli,Mumbai-400 018 / Form 45 (122 A) permission issued vide permission no. IMP-237-2010 dated 23th March 2010 / Pneumococcal Saccharide conjugate vaccine (Adsorbed), 13 valent Suspension
Source: M/s Wyeth Leverli vaccines, havant, Hampshire, England. / For the Active immunization for the prevention of disease cause by streptococcus pneumonia serotypes 1,3,4,5,6A,7F, 9V,14, 18C,19A,19F & 23 F (including species, meningitis, bacteraemia, pneumonia, & Acute otitis media ) in infants & children from 2 months to 5 years of age / Injectable (IM)
  1. 31
/ Panacea Biotec Ltd.,B-1 Ext/A-27,Mohan Co-opertae Indl.Estate ,Mathura Road,New-delhi-110 044 / Form 46 (122 B) permission issued vide permission no. MF 822/10dated 21th Sep 2010 / DTwP-vaccine (adsorbed) / For the primary immunization of infants at or above the age of 6 weeks & of children through 6 years of age against Diphtheria, Tetanus & Whooping cough / Injectable (IM)
  1. 32
/ Biol.E.Ltd.,18/1 and 3,Azamabad,Hyderabad-500 020 / Form 46 (122 B) permission issued vide permission no. MF 843/10 dated 29th Sep 2010 / Liquid pentavalent vaccine / Active immunization of Against Diphtheria, pertussis, tetanus, Hepatitis b, HIb type b infection / Injectable (IM)
  1. 33
/ Serum Institute of India Ltd., 212/2,Hadapsar,Pune-411 -028 / Form 46 A (122 B) permission issued vide permission no. Bulk800/10 dated 18th Oct ,2010 / Haemophilus type b (HIb) conjugate vaccine bulk / NIl / Nil