125742 S47 M3 32p3 manufacturer diluent

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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 0.9% Sodium Chloride, USP 
Diluent 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)
Pfizer Healthcare India Pvt. Ltd. Plot 
No. 116, 117, 118, 119, 111 (Part) and 
123 (Part)Jaw aharlal Nehru Pharm a 
City (SEZ) Paraw ada 
MandalVisakhapatnamAndhra Pradesh 
531019 IndiaFEI# 3008316085
DUNS # 860037912Manufacture, testing and release 
(of 10mL size diluent vials)
Hospira is a wholly owned subsidiary of Pfizer Inc.
090177e197ccbc5c\Approved\Approved On: 13-Aug-2021 12:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149585