125742 S57 M3 32p3 manufacturer diluent

Pfizer Documents (PHMPT/FDA)

Pfizer Bla Submission

Pfizer 16 Plus Documents

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Document text

BNT162b2
3.2.P.3.1. Manufacturer(s) –[DILUENT]
PFIZER CONFIDENTIAL
Page 13.2.P.3.1. MANUFACTURER(S)
Table 3.2.P.3.1-1 lists the sites that have responsibilities in the production of 0.9% sodium 
chloride, USP diluent and their specified functions.
Table 3.2.P.3.1 -1.Sites and Responsibili ties for Diluent (0.9% Sodium Chloride, 
USP) Manufacture 
Site FEI / DUNS Numbers Responsibility
Fresenius -Kabi USA, LLC Manufacture, testing and release 
(of 2 mL size diluent vials)
Hospira, Inc Manufacture, testing and release 
(of 10mL size diluent vials)
Hospira is a wholly owned subsidiary of Pfizer Inc.
090177e197d56f80\Approved\Approved On: 17-Aug-2021 18:58 (GMT)
(b) (4)
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FDA-CBER-2021-5683-1149876