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BNT162b2
1.4.2. Statement of Right to Reference
PFIZER CONFIDENTIAL
Page 11.4.2. STATEMENT OF RIGHT T O REFERENCE
The following Drug Master File (DMF) / Master File (MF) Letters of Authorization are
provided herein as presented in Table 1.4.2-1.
Table 1.4.2-1.DMF Letters of Authorization
DMF/ MF Holder DMF/ MF
NumberDMF /MF Subject Reference Inform ation
Gerresheimer Buende
GmbHDMF 9543 Type I Tubular Containers 2 mL T ype I borosilicate glass
vial, 13 mm finish
Gerresheimer Buende
GmbHDMF 15209 Containers made from tubular
glass as ampoules, bulk
syringes, cartridges, and vials
up to 100ml to be used as
primary packaging containers
for pharmaceutical and
medicinal products2 mL T ype I borosilicate glass
vial, 13 mm finish
Schott Hungary Kft. DMF 011793 Primary packaging material 2 mL T ype I borosilicate glass
vial, 13 mm finish
Schott AG DMF 011820 Glass vials manufactured in
Mullheim, Germany2 mL T ype I borosilicate glass
vial, 13 mm finish
Schott North America,
Inc.DMF 012683 Glass products manufactured in
Lebanon, Pennsylvania2 mL T ype I borosilicate glass
vial, 13 mm finish
Schott Kaisha Private
LimitedDMF 031786 Glass ampoules, glass vials,
glass cartridges and glass
syringes2 mL T ype I borosilicate glass
vial, 13 mm finish
Stevanato Group S.p.A. DMF 011321 0612090.5636 –VIAL VB
2mL 16.25x0.85x312 mL T ype I borosilicate glass
vial, 13 mm finish
Datwyler Pharma
Packaging Belgium NVDMF 10953 Rubber compounds FM457/0
090177e19700abf8\Approved\Approved On: 12-May-2021 02:55 (GMT)
FDA-CBER-2021-5683-0225039