Central Inspection Plan Using Risk Based Approach Of Vaccine Manufacturing Units for 2015
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1 AEFI ed/ A NORTH ZONE 1 M/s Biomed Pvt. Ltd, C-96, Site I, Bulandshahar Road, Ind. Area, Ghaziabad. 2 M/s Pan Era Biotec Pvt. Ltd, Ambala Chandigarh Highway, Lalru, Punjab. Oral Polio Vaccine IP, Vi Polysaccharide Typhoid Vaccine (Bio Typh TM ), Vi Polysaccharide Typhoid Vaccine (Shan TM ) Meningococal Polysaccharide Vaccine, Haemophilus Type-B Conjugate Vaccine and Veterinary. Hepatitis B Vaccine (r DNA) IP (Bulk), Hepatitis B Vaccine (r DNA) BP (Bulk), Hepatitis B Vaccine (r DNA) Bulk drug substance & Haemophilus Type b Conjugate (PRP - TT) BP (Bulk). Bulk purified Diphtheria Toxoid, Bulk purified Tetanus 29 & 30 Sep by & State 08 & 09 by & State from CDL Follow up No Nil 1 st Quarter Follow up Follow up No Nil 1 st Quarter Follow up Page 1 of 10
2 AEFI ed/ 3 M/s Panacea Biotec Ltd, Vaccine Division, A- 241, Okhala Ind. Area, Phase I, New Delhi 20 Toxoid Pooled Bulk of Whole Cell Pertussis. Poliomyelitis Vaccine, Live, (Oral), Trivalent IP Monovalent Oral Polio Type 1 Vaccine Monovalent Oral Polio Type 3 Vaccine, Bivalent Poliomyelities Vaccine Live, (Oral) Injectable vaccine I.e. Easy four (DTwP+CRM Hib), Easyfive Ecovac 4 (DTwP-Hep B), (DTwP+CRM Hib+ Hepatitis B), Enivac HB [Hepatitis B Vaccine (rdna) IP, HIB. 10 & 11 by & State from CDL Follow up Nil No Nil I st Quarter Follow up Follow up Page 2 of 10
3 AEFI ed/ 4 M/s Panacea Biotec Limited, Malpur, Baddi, Tehsil- Nalagarh, Distt. Solan, Himachal Pradesh. 5 Bharat Immunological s & Biologicals Corporation Limited (BIBCOL), Village Chola, Dist. Bulandshahar, U. P. Recombinant Hepatitis B Vaccine IP/BP, DTwP-Hib(Easyfour), DTwP-Hib-Hepatitis B (Easy five), DTwP-Hib-TT (Easyfive), DT wp-hepatitis B (Ecovac-4), Hep B (Enivac HB), Hib (Novohib), Salk based IPV Vaccine (Polprotec), Haemophilus type b conjugate vaccine BP & DTwP Oral Polio Vaccine IP Trivalent and Monovalent (Type-1, Type-2 & Type 3) 10 & 11 by & State 13 & 14 Nov by & State Follow up No No Nil 1 st Quarter Follow up No Nil 1 st Quarter Follow up Page 3 of 10
4 AEFI ed/ 6 M/s Central Research Institute, Distt. Solan (HP) B SOUTH ZONE Diphtheria, Tetanus & Pertusis Vaccine (Adsorbed), Concentrated Diphtheria, Tetanus Pertusis Vaccine (Adsorbed), Tetanus Vaccine (Adsorbed), Diphtheria & Tetanus Vaccine. 01 & 02 By central, state Drugs inspector from CDL Follow up No Nil 1 st Quarter Follow up 2 nd Quarter Follow up 1 M/s. Green Signal Biopharma, Pvt. Ltd., 49, Pappankuppam Village, Gummidipoond i, Chennai Bacterial BCG Vaccine (Freeze- Dried) IP / BP / USP / EP 22 & 23 By central, state Drugs inspector Follow up Inspection No Nil 2 nd Quarter Follow up Page 4 of 10
5 AEFI ed/ 2 M/s Human Biologicals Institute (A division of Indian Immunologicals Limited) Kozhipannai, Pudumund Post, Udhagamandala m Tamil Nadu Viral Rabies Vaccine (Vero Cell) IP, BP,USP, 19 & 20 By central, state Drugs inspector No Nil 1 st Quarter Follow up 3. Ranbaxy Laboratories Limited, Survey 16, Ekarajapura, Siddlaghatta Road, Hoskote, Bangalore Heamphilus Influenze Type B Conjugate Vaccine 2.Vi Capsular Polysaccharide Typhoid vaccine 12 & 13/11/2013 from CDL, Compliance verification of previous dated 22 & 23/03/2012 No Nil 2 nd Quarter Follow up Page 5 of 10
6 AEFI ed/ C WEST ZONE 1 M/s. Serum Institute of India Ltd, 212/2 Hadapsar, Pune M/s. Haffkine Biopharmaceu tical Corporation Ltd. ( HBPCL), Parel, Mumbai TT, DT, DPT, Rabies, Hib, Meningococcal A Conjugate vaccine, Influenza vaccine, BCG, Measles, Rubella, MMR,flu vaccine for TT,DTP HiB, DTP HiBHep.B, Rabies vaccine,h1n1 OPV 21 to 22 November, 2014 by of inspectors inspectors Permission to commence additional vaccine g facility in SEZ- 1C/2 nd floor. For verification of CAPA submitted to WHO related to assessment of acceptability of OPV. No Yes, Investigated and ed 1 st Quarter Follow up No Nil 2 nd Quarter Follow up 3 M/s Glaxo Smith Kline Asia Pvt. Ltd. Nasik Labeling and packaging of Inactivated Hepatitis A, Typhoid Polysaccharide Vaccine, Rotavirus, DTP, DTP+ Hepatitis inspectors Renewal of Mfg. License in form 28- D N0 Nil 2 nd Quarter Follow up Page 6 of 10
7 AEFI ed/ B, Varicella Vaccine D HYDERABAD 1 Bharat Biotech International Ltd. Genome Valley, Turkapally Shameerpet (Mandal) Hyderabad Biological E. Limited D-4-34 Gaganpahad Rajendra Nagar Mandal, R.R., Dist., A.P. Hepatitis B vaccine, VI Polysaccharide Typhoid vaccine, Hib, DTP+Hib+Hep, Rabies vaccine Dedicated bulk antigen facility of TT 22 to 24- Sep from CDL, & for Pre-WHO PQ audit for verification of CAPA for Oral Polio Vaccine No Nil 1st Quarter ) No Nil 2nd Quarter Page 7 of 10
8 AEFI ed/ 3 M/s Human Biologicals Institute (A Division of Indian Immunological Limtied) Rakshapuram, Gachibowli, Hyderabad Hepatitis B vaccine, Tetanus Toxoid vaccine (Adsorbed), DTP vaccine For Annual Audit Inspection & For product complaints NA Yes, Investigated and ed with response to product complaints (DTP Vaccine IP B.No- TAG05A/14 1st Quarter 4 M/s. Biological E. Limited 18/1 & 3,Azamabad, Hyderabad, AP DTP bulk, JE Vaccine bulk, TT, bulk 20 to 22- No Nil 2nd Quarter 5 M/s. Dano & Biological Pvt. Limited, 575, Sivareddyguda, GhatkesarMand al, R.R. Dist Dedicated bulk antigen facility of TT from CDL, No Nil 2nd Quarter Page 8 of 10
9 AEFI ed/ 6 M/s. Biological E. Limited, Plot no. 1, SP Biotechnology Park Phase II, Kolthru village, Shamarpeet, Madal, Ranga Reddy, Dist., A.P. DTPw (Whole cell), Diptheria, Pertusis Hepatitis B vaccine bulk, JE Vaccine, TT, Hepatitis B, DTP+ Hep+Hib 18 & 19 from CDL, No Nil 2nd Quarter 7 M/s. Shantha Biotechnics Ltd. Survey 274, Arthvelli Village, MedchalMandal, Ranga Reddy District, Andhra Pradesh Hepatitis B vaccine, DTP, DTP+Hepatitis B, DTP+ Hepatitis +Hib, TT, Hib, DTP+Hib, Oral Cholera Vaccine, Hepatitis B vaccine bulk, DTP bulk, TT, TT bulk, DTP+ Hep+Hib bulk 18 & 19 from CDL, No Nil 4th Quarter Page 9 of 10
10 AEFI ed/ E AHMEDABAD 1 M/s Cadila Healthcare Limited, Sarkhej-Bavla, NH-8A,Village Moraiya, District Ahmedabad. 2 M/s Chiron Behring Vaccine Ltd Plot No 3502, G.I.D.C Estate, P.O. 136, Ankleshwar, Gujarat. Inactivated Influenza vaccine (Whole Virion), Rabies vaccine Rabies vaccine 11 & 12 July 2014 by & State from CDL, 09 & 10 July 2014 by & State No Nil 2nd Quarter Follow up 4th Quarter No Nil 2nd Quarter Follow up 4th Quarter Note: 1. Additionally, Inspections for selected prequalified vaccine facilities shall be planned as and when Inspections are planned by WHO for prequalification and Central Inspection Plan shall be updated accordingly. Page 10 of 10
Panacea Biotec. Rank: 3. Basic Information: Company Overview:
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