125742 S2 M1 loa dmf 011820 vials
Document text
Date: September 22, 2020 DMF#: 011820 Holder: SCHOTT AG Subject: GLASS VIALS MANUFACTURED IN MULLHEIM, GERMANY. Letter of Authorization for: Entire DMF 011820 SCHOTT AG hereby authorizes the following company to incorporate by reference information regarding packag- ing material in DMF 011820 into any application filed by this company for their product. We also authorize the FDA to review all informati on in DMF 011820 when considering any application filed by this company. Information to be referenced: Entire Type III DMF 011820, Date of Submission: December 22, 1995 Company: Pfizer Agent for BioNTech RNA Pharmaceuticals GmbH 500 Arcola Road 19436 Collegeville, PA USA The DMF holder states that DMF 011820 is current and will comply with the statements made within it. We request that all information in this file be treated as confidential within the meaning of 21 CFR 314.420. Sincerely, SCHOTT AG Stefanie Stühmer Customer Service SCHOTT AG, Müllheim SCHOTT AG Industriestrasse 3 D-79379 Muellheim -Baden Germany Phone +49 (0) 7631 36 85 0 Fax +49 (0) 7631 36 85 95 www.schott.com/pharmaceutical_systems Food and Drug Administration Center for Drug Evaluation and Research Central Document Room 5901 -B Ammendale Road Drug Master File Staff Beltsville MD 20705 -1266 USA 090177e196a0f1cd\Approved\Approved On: 26-Mar-2021 06:12 (GMT) FDA-CBER-2021-5683-0225036