125742 S2 M3 32s2 manufacturer

Pfizer Documents (PHMPT/FDA)

Pfizer Bla Submission

Pfizer 16 Plus Documents

1

Document text

BNT162b2
3.2.S.2. 1Manufacturer(s)
PFIZER CONFIDENTIAL
Page 13.2.S.2.1. MANUFACTURER(S)
Table 3.2.S.2.1 -1 lists the sites that have responsibilities in the production of BNT162b2 drug 
substance and their specified functions.
Table 3.2.S.2.1-1. Sites and Responsibilities for Manufacture and Testing of 
BNT162b 2 Drug Substance
Site FEI / DUNS Numbers Responsibility
(Pfizer, Andover, ) (Pfizer, Andover 
Building  Building and 
Building  Wyeth BioPharma Division of 
Wyeth Pharmaceuticals, LLCa
1 Burtt Road 
Andover, MA 01810
United StatesFEI: 1222181
DUNS: 174350868: Manufacture 
of drug substance
Bldg.  Release and 
Stability T esting
Pfizer Inc
875 Chesterfield Parkway West
Chesterfield, MO 63017
United StatesFEI: 1940118
DUNS: 00495 4111Release and Stability Testing 
a.The legal entity name change from Wyeth BioPharma Division of Wyeth Pharmaceuticals was changed at 
the acquisition by Pfizer in 2009, since then the Wyeth Pharmaceuticals manufacturing site in Andover, 
Massachusetts belongs to Pfizer’s production sites and is embedded in Pfizer´s GMP system .  Pfizer w ill be 
utilized throughout the CTD.
090177e196e974df\Approved\Approved On: 10-May-2021 18:34 (GMT)
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FDA-CBER-2021-5683-1149291