Document text
01/28/2022
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
Adrienne Stafford, Director, Pfizer Global CMC - Vaccines
4300 Oak Park Road
Sanford NC
27330919-708-6173
[email protected]
125742 0045
[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
10
(b) (6)
FDA-CBER-2022 5812-0163468
Response to 25 January 2022 Information Request regarding and Environmental Assessment/Categorical Exclusion and FDA form 356h
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
10
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0163469
Adrienne Stafford, Director, Global CMC - Vaccines, Pfizer Inc. 01/26/2022
919-708-6173 [email protected]
4300 Oak Park Road
Sanford NC
United States of America 27330
Adrienne
StaffordDigitally signed by Adrienne Stafford
DN: cn=Adrienne Stafford, o, ou,
email=adriennestafford@pfizer com,
c=US
Date: 2022 01 26 19:38:19 -05'00'
10
(b) (6)
FDA-CBER-2022-5812-0163470
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
410
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0163471
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
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0163472
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
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0163473
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
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0163474
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)
810
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0163475
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
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0163476
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
(b) (6)
(b) (6)
(b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2022-5812-0163477