Document text
07/01/2022
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
Gosia Mineo, Director, Global Regulatory Affairs - Vaccines
125742 45
[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-2022 5812-0163588
Revised USPI in response to FDA 29 June 2022 request for replacement to date of Package Insert for COMIRNATY in Individuals 12 Years of Age and Older
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, DMF 012683, DMF 031786, DMF 15911
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FDA-CBER-2022-5812-0163589
Revised USPI in response to FDA 29 June 2022 request for replacement to date of PI for COMIRNATY in Individuals 12yo
Gosia Mineo, Director, Global Regulatory Affairs - Vaccines 07/01/2022
Gosia MineoDigitally signed by Gosia Mineo
DN: o=Pfizer Inc, cn=Gosia
Mineo
Date: 202207 01 10:12:11 -04'00'
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FDA-CBER-2022-5812-0163590
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-2022-5812-0163591
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
510
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FDA-CBER-2022-5812-0163592
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)
610
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FDA-CBER-2022-5812-0163593
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)
710
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FDA-CBER-2022-5812-0163594
BioNTech Manufactuing GmbH
Emil-von-Behring-Str. 76 3011406957
Marburg N/A
Germany 35041313270335
Manufacture of drug substance, Drug substance testing
Labor LS SE & Co KG
Mangelsfeld 4,5,63002807481
Bad Bocklet
Germany 97708314929072
Drug substance testing (Bioburden)
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FDA-CBER-2022-5812-0163595
BioNTech Innovative Manufacturing Services (BNT IMFS) GmbH
Vollmersbachstrasse 663014049480
Idar-Oberstein
Germany 55743537365801
Drug substance testing
BioNTech Manufacturing GmbH
An der Goldgrube 3015003158
Mainz
Germany 55131314382536
Christoph Prinz
Drug substance testing
910
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FDA-CBER-2022-5812-0163596
Hospira, Inc
1776 North Centennial Drive1925262
McPherson Kansas
United States 67460030606222
Ian MacKellar
N/A
Fill and finish, Primary packaging, Secondary packaging, Drug product testing
Sandoz GmbH
1010
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FDA-CBER-2022-5812-0163597