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To: Food and Drug Administration
Center for Biologics Evaluation and Research
Document Control Center
10903 New Hampshire Ave.
Building 71, Room G112
Silver Spring, MD 20993-0002
Copy to Pfizer Inc. as US Agent for BioNTech RNA
Pharmaceuticals GmbH
500 Arcola Road
Collegeville, PA 19436
USA
Piombino Dese (Italy), August 25, 2020
DMF Type III no. #011321
Submission date: Submitted on January 15, 1995 revised on May 22, 2015
DMF Holder: Stevanato Group S.p.A.
Letter of authorization for: 0612090.5636 VIAL VB 2mL 16.25x0.85x31
Dear DMF Staff,
Stevanato Group S.p.A. hereby authorizes Pfizer Inc. to incorporate by reference
information 0612090.5636 VIAL VB 2mL 16.25x0.85x31 in DMF Type III #011321
into any application filed by Pfizer Inc. We also authorize the FDA to review the
aforementioned specific information in DMF Type III #011321 when considering any
application filed by Pfizer Inc.
Item:0612090.5636 VIAL VB 2mL
Drug product: SARS-COV-2-mRNA Vaccine
Drawing: 5636/05-02
Referenced Section: Module 3, Section 3.2.P.1 List of products ANNEX A Attachment 530
Stevanato Group S.p.A states that DMF Type III #011321 is current and Stevanato Group
S.p.A will comply with the statements made within it. Stevanato Group S.p.A will notify
FDA through an amendment to DMF#011321 of any addition, change, or deletion of
information in the DMF. Stevanato Group S.p.A will also notify in writing Pfizer Inc. that
an addition, change, or deletion of information has been made to the DMF .
Sincerely,
Andrea Salmaso
Regulatory and Scientific Affairs Manager
Stevanato Group S.p.A.
Via Molinella 17, 35017- Piombino Dese - Padova - Italy
Ph. +390499318008 F. +39 049 9366151
[email protected]
FDA-CBER-2021-5683-0225034