Bharat Biotech. Hyderabad. Type of PAC (Supplement and Notifiable / Permission Granted by CDSCO) S. No Product

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1 Bharat Biotech Hyderabad S. No Product Type of PAC (Supplement and / Permission Granted by CDSCO) PAC Details Date of NOC in manufacturing process of Oral Polio F.No /BHARAT/(PACOPV)/13-BD in container closure of Poliomyelitis s (mopvs, bopv & topv), Live (Oral) Oral Polio s (mopv, bopv, topv) F.No /Bharat/PACPolio/13-BD Manufacture of Bivalent Poliomyelitis Type 1 & 3 Live (Oral)- 1.0 ml 10 doses presentation F.No /Bharat/PACbOPV/15-BD Revision of Package Insert of Biopolio B1 & 3 (Bivalent Poliomyelitis Type 1 & 3 Live (Oral)

2 F.No.12-26/Bharat-Bio/PAC-BiopolioB1/3/16-BD PAC for in the seal of Bivalent Poliomyelitis Vaccinr Type 1&3 Live (Oral) F.No12-97/BBIL/PACbOPV/16-BD Dated: Dy No For tightening the storage condition for Purified Inactivated Japanese Encephalitis Virus Bulk from 5 ± 3 C to -70 C ± 5 C Supplement F.No /BHARAT/(PACJE)/14-BD in the preservative for Purified Inactivated Japanese Encephalitis in PFS (JENVAC-PFS) Purified Inactivated Japanese Encephalitis Virus F.No /BBIL/PACJENVAC- PFS/15-BD Extension of shelf life for Purified inactivated Japanese Encephalitis Virus Bulk from 24 months to 36 months when stored at -70 C ± 5 C F.No /BBIL/PACJENVAC/16-BD

3 in the International nonproprietary name(inn) of JENVAC and JE Shield F. No /Bharat/PAC-JENVAC PFS/15BD Revision of package insert of Japanese Encephalitis Inactivated (adsorbed, human) F.No /BBIL/PAC-JE Vac/16-BD NOC for extension of shelf life of Rotavirus 116E Bulk (Live Attenuated) from 72 months to 120 months F.No /Bharat/PACRotavirus/14-BD PAC in the specifications for the drug product 3 Live Attenuated Oral Rotavirus 116 F.No /BBIL/PACRotavirus/16-BD d passage level of Rotavirus 116E- Working Virus Bank. F.No /BBIL/PACRotavirus/16-BD PAC for Revision of Packaging Material of Rotavirus (Live Attenuated, Oral)

4 F.No. : /BBIL/PACRotavirus/16-BD 4 Diphtheria, Tetanus & Pertussis (Comvac 3) Manufacture of Diphtheria, Tetanus and Pertussis in PFS Presentation /BBIL/PAC-DTP /15 BD s for elimination low vaccume drying step from the Bioprocess of Hib- PRP Bulk Haemophilus influenzae type b (Hib) conjugate F.No /BHARAT/(PACHib+J138 PRP-TT)/13-BD in drug substance manufacturing process of purified HIB -PRP-TT conjugate bulk (drug substance) F.No /Bharat Biotech/PAC- Hib PRP-14-BD

5 extension of shelf life of Haemophilus Influenzae Type b purified RP- TT conjugate Bulk (drug substance) from 12 months to 24 months F.No /BBIL/PAC-Hib PRP TT Bulk/15- BD Extension of shelf life from 2 years to 3 years for rabies vaccine (Vero Cell cultured) INDIRAB File No /BBIL/09BD/suppl Rabies, Human Tightening of the storage condition for purified BPL inactivated bulk of rabies antigen F.No /BHARAT/ (PACRabies)/ 13- J156BD Deletion of the acceleration degradation test from the release specification of rabies vaccine-ip F.No.12-13/BHARAT/ J158(PACRabies)/ 14- BD Extension of shelf life of Purified Rabies (Bulk) from 12 months to 24 months

6 F.No /Bharat/P AC-RabiesBulk/13-BD Addition of M/S. Global Pharma as additional source (supplier) of diluent 0.9% w/v NaCl which is used in manufacturing of Rabies & Haemophilus Influenzae Type b conjugate F.No.12-33/BHARAT/ PACNaCl/ 14-BD Recombinant Hepatitis B Manufacture of Recombinant Hepatitis B (Thiomersal free) in PFS presentation F.No.12-81/BBIL/PACRevacB/15BD change Shelf life extension of Vi Capsular Polysaccharide Typhoid 0.5ml in PFS & 5.0ml in vial from 24months to 36 months Vi Capsular Polysacchari de Typhoid Supplement change change F.No /Bharat/PACVi Capsular Typhoid /14-BD Elimination of low vacuum drying step from the Bioprocess (Bulk) F.No /BHARAT/(PAC-CDSTyphoid) Shelf life extension of Vi- Capsular Polysaccharide Typhoid Bulk from 24 months to 36 months F.No /Bharat/PACTyphoid/14-BD Usage of liquid Bulk for conjugation in manufacturing of Typhoid Vi- Capsular Polysaccharide- Tetanus Toxoid conjugate Bulk F.No.12-47/BBIL/PACTyphoid /15-BD

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