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September 17, 2020
Drug Master File # 10953 - Letter of Authorization
Our internal reference: B4013 update 1
Page 1 of 2
September 17, 2020
Our internal reference : B4013 update 1
DMF#: 10953
Holder: Datwyler Pharma Packaging Belgium NV
Subject : Rubber Compounds
Letter of Authorization for:
compound FM457/0 , located in record # 026, Update 3, pages 1-7, dated April 21,
2020.
Dear DMF Staff:
Datwyler Pharma Packaging Belgium NV hereby authorizes Pfizer Inc. as US Agent for
BioNTech RNA Pharmaceuticals GmbH to incorporate by reference information regarding
compound FM457/0 in DMF 10953 into a BLA application filed by Pfizer Inc. as US Agent for
BioNTech RNA Pharmaceuticals GmbH, 500 Arcola Road, Collegeville, PA, 19436, USA, for
their product SARS-COV-2-mRNA Vaccine . We also authorize the FDA to review the
aforementioned specific information in DMF 10953 when considering a BLA application filed
by Pfizer Inc. as US Agent for BioNTech RNA Pharmaceuticals GmbH.
Datwyler Pharma Packaging Belgium NV states that DMF 10953 is current and Datwyler
Pharma Packaging Belgium NV will comply with the statements made within it. Datwyler
Pharma Packaging Belgium NV will notify FDA through an amendment to DMF 10953 of any
addition, change, or deletion of information in the DMF. Datwyler Pharma Packaging Belgium
NV will also notify in writing Pfizer Inc. as US Agent for BioNTech RNA Pharmaceuticals GmbH
that an addition, change, or deletion of information has been made to the DMF.
Sincerely,
Food and Drug Administration
Center for Biologics Evaluation and Research
Document Control Center
10903 New Hampshire Ave.
Building 71, Room G112
Silver Spring, MD 20993-002
USA
Contact
Renaud Janssen, Ph.D.
Head of Regulatory Affairs and
Chemical Compliance
T +32 (0)11 59 08 11
[email protected]
090177e196a0ee6b\Approved\Approved On: 26-Mar-2021 06:10 (GMT)
FDA-CBER-2021-5683-0225032
September 17, 2020
Drug Master File # 10953 - Letter of Authorization
Our internal reference: B4013 update 1
Page 2 of 2
Tabassam Sharif
Manager Regulatory Affairs
Datwyler Pharma Packaging Belgium NV
Phone : +32 11 59 08 11
Fax : +32 11 31 40 86
[email protected]
090177e196a0ee6b\Approved\Approved On: 26-Mar-2021 06:10 (GMT)
FDA-CBER-2021-5683-0225033