Novartis Pharmaceutical Manufacturing GmbH

Kundl, AustriaFEI 3027031635API manufacture registered

Novartis Pharmaceutical Manufacturing GmbH is a drug establishment in Kundl, Austria, registered with the US FDA under FEI 3027031635. Its registered operations are: Analytical testing, API manufacture. 13 EU/UK GMP certificates are matched to this site, 4 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 (13)

DocumentAuthorityInspectionSource
484296-105553013
GMP certificate
Competent authority of Austria4 Dec 2025
within 3-year review window
EudraGMDP
484296-103675257
GMP certificate
Competent authority of Austria4 Dec 2025
within 3-year review window
EudraGMDP
484296-105579653
GMP certificate
Competent authority of Austria4 Dec 2025
within 3-year review window
EudraGMDP
484296-105654285
GMP certificate
Competent authority of Austria4 Dec 2025
within 3-year review window
EudraGMDP
484296-102184789
GMP certificate
Competent authority of Austria15 Feb 2023
outside 3-year review window
EudraGMDP
484296-101532805
GMP certificate
Competent authority of Austria15 Feb 2023
outside 3-year review window
EudraGMDP
484296-104634283
GMP certificate
Competent authority of Austria15 Feb 2023
outside 3-year review window
EudraGMDP
484296-102505016
GMP certificate
Competent authority of Austria15 Feb 2023
outside 3-year review window
EudraGMDP
484296-104078701
GMP certificate
Competent authority of Austria15 Feb 2023
outside 3-year review window
EudraGMDP
484296-103654468
GMP certificate
Competent authority of Austria15 Feb 2023
outside 3-year review window
EudraGMDP
484296-103050828
GMP certificate
Competent authority of Austria15 Feb 2023
outside 3-year review window
EudraGMDP
484296-104484913
GMP certificate
Competent authority of Austria15 Feb 2023
outside 3-year review window
EudraGMDP
484296-104615153
GMP certificate
Competent authority of Austria15 Feb 2023
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