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Ref: Letter DMF Format Update November 2, 2015
Primary Packaging Glass
Re: Letter of Authorization to reference Type III DMF #9543
Type I Tubular Containers
Gerresheimer Glass Inc. hereby authorizes Pfizer Inc. as US Agent for BioNTech RNA
Pharmaceuticals GmbH, 500 Arcola Road, Collegeville, PA 19436 to incorporate by refe rence DMF
9543 into any IN D, NDA, ANDA, IDE, PMA, ANADA, BLA or DMF filed by Pfizer, Inc. .
DMF 9543 was filed by Gerresheimer Glass Inc. on February 7, 1992.
We hereby authorize your office to review the aforementioned specific information in DMF 9543 when
considering any IND, NDA, ANDA, BLA, IDE, PMA, ANADA, amendment, or supplement filed by
Pfizer, Inc. We request that all information in this file be treated as confidential to the extent possible
in accordance with 21 CFR 314.430 and 21 CFR 20.61, and that no information from this file be
provided to any unauthorized persons without our written consent. T his authority is granted for as
long as this DMF is active, or until the FDA is notified to rescind the authority.
The materials furnished will be manufactured in accordance with DMF 9543 and in compliance with
good manufacturing practices. The DMF holder states that DMF 9543 is current and the holder will
comply with the statements made within it. Notification to Pfizer, Inc. and an appropriate notification
to FDA and this file will be made for changes that impact the subject materials of this letter.
Yours sincerely,
James McFarland
Senior Regulatory Manager
Gerresheimer Glass Inc.
Adrienne Stafford
Director, Global CMC, Pfizer
4300 Oak Park Road
Sanford, NC 27330
919-566-4701
Gerresheimer Glass Inc.
Morganton Plant
114 Wamsutta Mill Road
Morganton, NC 28655
USA
Senior Regulatory Manager
James McFarland
Telephone 1.828. 604.1429
E-Mail james .mcfarland @gerresheimer.com
Internet www.gerresheimer.com
September 2, 2020 Food and Drug Administration
Center for Biologics Evaluation and Research
Document Control Center
10903 New Hampshire Avenue
Building 71, Room G112
Silver Spring, MD 20993 -0002
090177e196a0ecdf\Approved\Approved On: 26-Mar-2021 06:11 (GMT)
FDA-CBER-2021-5683-0779744