125742 S2 M3 32p4 novel excipients

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BNT162b2
3.2.P.4 .6 Novel Excipients (Non -Com pendial)
PFIZER CONFIDENTIAL
Page 13.2.P.4.6. NOVEL EXCIPIENTS (NON -COMPENDIAL)
The two novel lipid excipients used in the BNT162b2 drug product manufacturing are 
ALC-0159 (2 -[(poly ethylene glycol) -2000]- N,N-ditetradecy lacetamide) and ALC-0315 
((4-hydroxybutyl)azanediy l)bis(hexane -6,1-di yl)bis(2 -hexyldecanoate)). Additional 
information is provided in Section 3.2.A.3 Excipients [ALC-015 9] and Section 3 .2.A.3 
Excipients [ALC-0315] , respectivel y.Supportive nonclinical and clinical safet y data are 
provided in Section 2.4.4 Toxicology and Section 2.5.5 Overview of Safet y, respectivel y.
090177e19700a368\Approved\Approved On: 12-May-2021 08:23 (GMT)
FDA-CBER-2021-5683-1149046