Sanofi Pasteur India Pvt. Ltd., Mumbai
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1 Sanofi Pasteur India Pvt. Ltd., Mumbai S. NO. Product Name Variation Approval date and letter num 1 VAXIGRIP Strain modification - SH /96-DC(Pt-1) 2/3/ Pentaxim PFS with Notifiable change: Modification in container 12-06/Sanofi/Pac-Dtap-IPV needle closure system (Attached neddle)- variation dated 1.April MENOMUNE Inclusion of building (B56) Approved /SANOFI/ MENOMUNE/12-BD dated 4 PNEUMO 23 Update in release specification /SANOFI/PAC-Pneu BD dated 15.Jan IMOVAX POLIO (MD) IPV MD 12-08/Sanofi/PAC-IPV/14-30.July VERORAB Online Sterilization Approved with conditions. 91/SANOFI/PAC-Rabies/13 23.April ACT-HIB, PENTAXIM Process optimization 12-97/SANOFI/PAC-ActHib Pentaxim/13-BD dated VAXIGRIP Inclusion of building (B44) Approved 26.June.2014F.N 90/Sanofi/PAC-influenza/1 9 ACT-HIB Replacement of Pyrogen test with Bacterial IPC/VAC/Q/IP2014/F-01 da Endotoxin test for final lot of Hemophilus 02.Dec.2014 Influenza type b (Hib) vaccine.
2 10 IMOVAX POLIO Change in analytical method used for effective Acknowledgement inactivation IPV/13-BD 13.Apr VAXIGRIP Submission of french approval -NH /96-DC (Part-I) dated Strains modification 12 IMOVAX POLIO Bldg /Sanofi/PAC-IPV/13-17.Dec ACT-HIB, PENTAXIM Change in composition of the container closure 12-85/Sanofi/PAC-PENTAX system used for the staorage of conjugated 28.Apr.2015 haemophilus b polysaccharide bulk 14 VAXIGRIP SH Strain modification 12-68/96-DC (Part-I) dated 15 PNEUMO 23 Query Reply _ Change in release specification of /SANOFI/PAC-Pneu drugs substance and drug product BD dated 15.Jan IMOVAX POLIO, ISL 1 & 3 variation /Sanofi/PAC-IPV Bu TETRAXIM, dated 24.Jun.2015 PENTAXIM 17 IMOVAX POLIO, V L to 3000L scale up 12-01/Sanofi/PAC-Polio/1 TETRAXIM, 19.Jun.2015 PENTAXIM 18 PNEUMO 23 Optimization of the Filtration Sequence at the 12-14/Sanofi/PAC-Pneum Final Bulk Product and Filled Product Stages of dated 13.Mar.2015 the Pneumococcal Polysaccharide Vaccine in Syringe Presentation 19 IMOVAX POLIO Inclusion of building 44 (B44) in Val de Reuil as 12-26/Sanofi Pasteur/PAC an alternative building for blending and quality Vaccine/15-BD dated 17.A control of the Poliomyelitis concentrated trivalent
3 20 VAXIGRIP application to amend the Variation approval 12-21/Sanofi/PAC-VAXIGR letter: Inclusion of additional site (Sanofi BD Winthorop Industrie Le Trait France) for 28.Apr.2015 quality control testing and secondary packaging 21 Pentaxim PFS with Attached needle - request for amendment in 12-06/Sanofi/PAC-DTaP-IP needle PAC approval letter 28.Apr PENTAXIM, Variation - Pertussis immunogenicity assay; 12-75/Sanofi/PAC-Penta & TETRAXIM mice weight / age BD dated 05.Aug ADACEL, TRIPACEL Notifiable change - Reference Standard for 12-84/Sanofi Pasteur/PAC Pertussis Toxin Toxicity (CHO) Assay (CCR Pertussis/15-BD dated ) 24 ADACEL, TRIPACEL Gerresheimer Glass Incorporated as an 12-94/Sanofi/PAC-Adacel alternate vial supplier. BD dated 28.Jul ACT-HIB, PENTAXIM Notifiable change - change in purity test of 12-93/Sanofi/PAC-Pentaxi seeds and IPC test at fermentation stage dated 21.Dec IMOVAX POLIO (MD) 28-OVP /Sanofi/PAC-Polio V dated 04.Sep AVAXIM 80/160 Notifiable change - change in primary /Sanofi/PAC-HepA/ containers, plungers, syringe, 06.Oct TRIPACEL Replacement of Acelluar Pertussis Guinea pig 12-94/Sanofi/PAC-Adacel immunogenicity assay with Mouse immunogenicity BD dated 28.Mar.2016 assay. 29 ADACEL Replacement of Acelluar Pertussis Mouse 12-94/Sanofi/PAC-Adacel relative potency assay with mouse BD dated 28.Mar.2016 immunogenicity assay
4 30 ACT-HIB, PENTAXIM Notifiable change: Change in filtration process 12-20/Sanofi/PAC-Haemo of conjugated Haemophilus type b dated 28.Jun.2016 Polysaccharide Vacccine and End of Shelf Life specification for the Conjugate Haemophilus type b Polysaccharide vaccine 31 TYPHIM Vi Notifiable Change - End of Shelf Life /SANOFI/PAC-TYPH Specifications (with LC changes) dated 15.Jul ACT-HIB, PENTAXIM Supplement change: Addtion of New Building 12-17/Sanofi/PAC-HIB/16 V Feb.2016 Notifiable change: other associated changes 33 IMOVAX POLIO Attached needle 12-23/Sanofi/PAC-poliova 01.Mar VAXIGRIP Strain change SH-2016 for Adult and Pediatric 12-68/96-DC (Part I) 16.Feb VAXIGRIP HAI Variation + License conformance 12-27/Sanofi/PAC-Vaxigrip 09.May VERORAB PFS - requesting amendment in Post approval 12-76/85-DC/PAC-STR-VER change NOC dated 16.Feb TYPHIM Vi Variation - Notifiable change - Pilot ready to 12-45/Sanofi/PAC-Typhim submit - Addition of bioburden and Change in 04.May.2016 critical parameter tolerance ( / ) 38 MENACTRA B56 Variation - Supplement 12-51/Sanofi/PAC-MENAC dated 09.Dec AVAXIM 80/160 Change in QC profile of 2 raw materials - Fetal 12-31/Sanofi/PAC-Hepatit Calf Serum and Bovine Calf Serum dated 12.Sep TYPHIM Vi Notifiable Change - End of Shelf Life /SANOFI/PAC-TYPH Specifications (with LC changes) dated 15.Jul.2016
5 41 mopv1, OPVERO Notificable change - change in container closure 12-60/Sanofi/PAC-OPV/16 system used for storage of Poliomyelitis virus 06.Jul.2016 type 1 and 3 monovalent bulks 42 ACT-HIB, PENTAXIM Variation - Reference Standard for Free 12-46/Sanofi/PAC-Tetraxim Polysaccharide Content (Depolymerized PRP) Pentaxim/16-BD dated 24 Test for Haemophilus type b Conjugated Vaccine (Drug Product) 43 TETRAXIM CCDS update Variation 12-80/Sanofi/PAC-Tetraxim 14.Sep PENTAXIM, Notifiable change: Change of Reference 12-79/Sanofi/PAC-Tetraxim TETRAXIM Standard Batch (new batch APG FA491309) Pentaxim/16-BD used for antigenicity test for Purified Pertussis 04.May.2016 Toxoid in solution component (intermediate of Drug Substance). 45 TETRAXIM CCDS update Variation 12-80/Sanofi/PAC-Tetraxim 14.Sep PENTAXIM CCDS update Variation 12-75/Sanofi/PAC-Pentaxi 47 IMOVAX POLIO, Reference Standard CCR# BSA 12-86/Sanofi/PAC-Poliomy TETRAXIM, Trivalent/16-BD dated 15. PENTAXIM 48 ACT-HIB, PENTAXIM Notifiable change: Act-Hib-Pentaxim 12-90/SANOFI/PAC-HBV/1 reference standard variation - FA CCR 10.Jun.2016 CCR n TYPHIM Vi reference standard molecular size /Sanofi/PAC-TYPHI determination. Clarification letter to DCGI and dated 08.Aug.2016 CDL that we want approval of 2 batch of Ref. Std.
6 50 TYPHIM Vi Variation - CCDS update /Sanofi/PAC-Typhim 51 IMOVAX POLIO CCDS update /Sanofi/PAC-PV/16 14.Sep VAXIGRIP Strain change NH for Adult, Pediatric 12-68/96-DC (PART I) date and Multidose (Md) 53 VAXIGRIP submission of variation Vaxigrip: Extension of /Sanofi/PAC-Inactiv the Contact Filtration Duration Vac/16-BD dated 08.Aug.2 54 VAXIGRIP CCDS Variation /Sanofi/PAC-Vaxigr 55 PENTAXIM, Tetraxim Pentaxim variation reference standard 12-79/Sanofi/PAC-Tetraxim TETRAXIM batch FA Pentaxim/16-BD 04.Oct VERORAB CCDS update Variation /Sanofi/PAC-Verora 57 VERORAB Notifiable Change - Declaration of a new /Sanofi/PAC- Rabie reference standard batch (PH206883) for BSA 9th Jan 2017 content test at Rabies Vaccine Finished Product stage. 58 ADACEL, TRIPACEL Notifiable change: Reference Standard 12-89/Sanofi/PAC-Adacel CPMRS2015 used in the Component Pertussis BD dated 25.Oct.2016 Mouse Immunogenicity Assay (CCR ) 59 HEXAXIM Variation - Notifiable Change - Reference /Sanofi/PAC-Hexax Standard and Mice changes (CCR , 9.Jan ) 60 ADACEL, TRIPACEL Notifiable change: New inhouse Pertussis Toxin 12-89/Sanofi/PAC-Adacel (PTx) reference standard lot (QOPT2015A) used BD dated 30.Nov.2016 in ELISA for quantitation of Pertussis Toxin
7 61 Vaxigrip SH 2017 Strain modification 12-68/96-DC(Pt-1) 7.Feb.2017
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