Pfizer Manufacturing Austria GmbH

Orth an der Donau, AustriaFEI 3011606091API manufacture registered

Pfizer Manufacturing Austria GmbH is a drug establishment in Orth an der Donau, Austria, registered with the US FDA under FEI 3011606091. Its registered operations are: Analytical testing, API manufacture. 14 EU/UK GMP certificates are matched to this site, 8 inspected within the last three years.

Sources: FDA Drug Establishments Current Registration Site (checked 2 Nov 2026); EudraGMDP; MHRA GMDP. Methodology

Registered operations

Business operations this establishment declares in its FDA registration. Registration is not an approval and says nothing about EU or UK GMP status.

Analytical testingAPI manufacture

GMP documents matched to this site (14)

DocumentAuthorityInspectionSource
482464-105357978
GMP certificate
Competent authority of Austria15 Jan 2026
within 3-year review window
EudraGMDP
482464-104923804
GMP certificate
Competent authority of Austria15 Jan 2026
within 3-year review window
EudraGMDP
482464-104232451
GMP certificate
Competent authority of Austria23 May 2024
within 3-year review window
EudraGMDP
482464-103485753
GMP certificate
Competent authority of Austria23 May 2024
within 3-year review window
EudraGMDP
482464-103430198
GMP certificate
Competent authority of Austria23 May 2024
within 3-year review window
EudraGMDP
482464-102570284
GMP certificate
Competent authority of Austria23 May 2024
within 3-year review window
EudraGMDP
482464-104087153
GMP certificate
Competent authority of Austria23 May 2024
within 3-year review window
EudraGMDP
482464-103513352
GMP certificate
Competent authority of Austria23 May 2024
within 3-year review window
EudraGMDP
482464-102410732
GMP certificate
Competent authority of Austria14 Sept 2022
outside 3-year review window
EudraGMDP
482464-102575628
GMP certificate
Competent authority of Austria14 Sept 2022
outside 3-year review window
EudraGMDP
482464-101555362
GMP certificate
Competent authority of Austria14 Sept 2022
outside 3-year review window
EudraGMDP
482464-102138416
GMP certificate
Competent authority of Austria14 Sept 2022
outside 3-year review window
EudraGMDP
482464-102594030
GMP certificate
Competent authority of Austria14 Sept 2022
outside 3-year review window
EudraGMDP
482464-101551683
GMP certificate
EU competent authority14 Sept 2022
outside 3-year review window
EudraGMDP

A GMP document is matched to this site when its address names the site's street and its city or postcode. In our latest internal review 59 of 60 sampled matches were the right site (not yet independently reviewed; measured match quality). Check the certificate's own address before relying on it. The three-year review window is the EMA guideline default after an inspection, not an official expiry date.

What this page does not show

  • Which substances are made here: DMFs and CEPs are filed by organisations, not sites, so we do not link substances to this site.
  • Capacity, scale, price or current availability: no regulator publishes these.
  • FDA inspection classifications for this site, which are not yet linked.

Other sites registered by the same company