Document text
08/16/2021
BioNTech Manufacturing GmbH
+49 (0) 6131 9084-7593 +49 (0) 6131 9084-390
An der Goldgrube 12
Mainz N/A
Germany 55131 [email protected]
117645848
2229
Elisa Harkins, Global Regulatory Lead, Pfizer Global Regulatory Affairs - Vaccines
500 Arcola Road
Collegeville PA
19426215-280-5503
845-474-3500
[email protected]
125742
[COVID-19 mRNA Vaccine (nucleoside modified)]
COMIRNATY
COVID-19 Vaccine (BNT162, PF-07302048)
Liquid 30 mcg Intramuscular
Active immunization to prevent COVID-19 caused by
SARS-CoV-2 in individuals 16 years of age
COVID-19; SARS-CoV-2; Disease caused by severe acute respiratory syndrome coronavirus 2; SARS-CoV-2 vaccination; COVID-19 vaccination
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FDA-CBER-2021 5683-1078617
Response to FDA 13 August 2021 Third Round of BLA Prescribing Information Comments
Pharmacia and Upjohn Company LLC (Pfizer)
7000 Portage Road
Kalamazoo MI
USA 490011810189
618054084
LNP production and bulk drug product formulation, Fill and finish, Primary packaging, Secondary packaging,
Drug product testing
IND 19736, DMF 012683, DMF 9543, DMF 15209, DMF 011793, DMF 011820, DMF 011321, DMF 10953,
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FDA-CBER-2021-5683-1078618
Response to FDA 13 August 2021 Third Round of BLA Prescribing Information Comments
Elisa Harkins, Global Regulatory Lead, Global Regulatory Affairs - Vaccines, Pfizer Inc. 08/14/2021
215-280-5503 845-474-3500 [email protected]
500 Arcola Road
Collegeville PA
United States of America 19426
Neda Aghajani
MemarDigitally signed by Neda Aghajani Memar
DN cn=Neda Aghajani Memar, o, ou,
[email protected], c=US
Reason I am signing on behalf of applicant
responsible party.
Date 2021.08.14 11 00 51 -04'00'8
FDA-CBER-2021-5683-1078619
Pfizer Manufacturing Belgium NV
Rijksweg 121000654629
Puurs N/A
Belgium 2870370156507
LNP production and bulk drug product formulation, Fill and finish, Primary packaging, Secondary
packaging, Drug product testing
Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC
1 Burtt Road1222181
Andover MA
United States 01810174350868
Manufacture of drug substance, Drug substance testing, Drug product testing
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FDA-CBER-2021-5683-1078620
Pfizer Inc
875 Chesterfield Parkway West1940118
Chesterfield MO
United States 63017004954111
Drug substance testing, Drug product testing
Pfizer Ireland Pharmaceuticals
Grange Castle Business Park Clondalkin3004145594
Dublin 22 N/A
Ireland N/A985586408
Drug product testing
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FDA-CBER-2021-5683-1078621
Hospira Zagrab Ltd.
Prudnicka cesta 603010630287
Prigorje Brdovecko
Croatia 10291500625201
Drug Product Release Testing (Sterility)
SGS Lab Simon SA
Vieux Chemin du Poete 103004186644
Wavre N/A
Belgium 1301283063907
Drug Product Release Testing (Sterility)
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FDA-CBER-2021-5683-1078622
Fresenius Kabi USA LLC
Anthony Giessert
N/A
manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP)
Hospira Inc.
Paul Lucas
manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP)
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FDA-CBER-2021-5683-1078623
Pfizer Healthcare India Pvt
manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP)
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FDA-CBER-2021-5683-1078624