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