125742 S2 M3 32p3 manufacturers
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BNT162b2 3.2.P.3.1. Manufacturer(s) 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 BNT162b2 drug product and their specified functions. Table 3.2.P.3.1 -1. Sites and Responsibilities for BNT 162b2 Drug Product Manufacture Site FEI / DUNS Numbers Responsibility Pharm acia & Upjohn Company LLCc 7000 Portage Road Kalamazoo, MI 49001 United StatesFEI: 1810189 DUNS: 618054084LNP production and bulk drug product formulation Fill and finish Primary packaging Secondary packaging Release and stability testing Pfizer Manufacturing Belgium NV Rijksweg 12 Puurs , 2870 BelgiumFEI: 1000654629 DUNS: 370156507LNP production and bulk drug product formulation Fill and finish Primary packaging Secondary packaging Release and stability testing Wyeth BioPharma Division o f Wyeth Pharm aceuticals LLCa 1 Burtt Road Andover, MA 01810 United StatesFEI: 1222181 DUNS: 174350868Release and stability testing Pfizer Inc. 875 Chesterfield Parkway West Chesterfield, MO 63017 United StatesFEI: 1940118 DUNS: 004954111Release and stability testing Pfizer Ireland Pharmaceuticals Grange Castle Grange Castle Business Park Clondalkin, Dublin 22 IrelandFEI: 3004145594 DUNS: 985586408Release and stability testing Hospira Zagreb Ltd.b Prudnička cesta 60 10291 Prigorje Brdovečko CroatiaFEI: 3010630287 DUNS: 500625201Release testing (Sterility) SGS Lab Simon SA Vieux Chemin du Poète 10 Wavre, 1301 BelgiumFEI: 3004186644 DUNS: 283063907Release testing (Sterility) 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. b.Hospira is a wholly owned subsidiary of Pfizer Inc. c. Pharmacia & Upjohn Company LLC is a a wholly owned subsidiary of Pfizer Inc. 090177e19700a16e\Approved\Approved On: 12-May-2021 08:14 (GMT) FDA-CBER-2021-5683-1149044