Sandoz GmbH

Kundl, AustriaFEI 3002806523API manufacture registered

Sandoz GmbH is a drug establishment in Kundl, Austria, registered with the US FDA under FEI 3002806523. Its registered operations are: Analytical testing, API manufacture, Labelling, Drug manufacture, Packaging, Relabelling, Repackaging. 28 EU/UK GMP certificates are matched to this site, 20 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 manufactureLabellingDrug manufacturePackagingRelabellingRepackaging

GMP documents matched to this site (28)

DocumentAuthorityInspectionSource
481921-105135964
GMP certificate
Competent authority of Austria9 Apr 2026
within 3-year review window
EudraGMDP
481921-104823957
GMP certificate
Competent authority of Austria27 Nov 2025
within 3-year review window
EudraGMDP
480012-104850659
GMP certificate
Competent authority of Austria4 Apr 2025
within 3-year review window
EudraGMDP
480012-103600843
GMP certificate
Competent authority of Austria4 Apr 2025
within 3-year review window
EudraGMDP
480012-105516416
GMP certificate
Competent authority of Austria4 Apr 2025
within 3-year review window
EudraGMDP
481921-104620227
GMP certificate
Competent authority of Austria14 Mar 2025
within 3-year review window
EudraGMDP
481921-104432587
GMP certificate
Competent authority of Austria14 Mar 2025
within 3-year review window
EudraGMDP
481921-103633811
GMP certificate
Competent authority of Austria14 Mar 2025
within 3-year review window
EudraGMDP
481923-102570144
GMP certificate
Competent authority of Austria5 Jun 2024
within 3-year review window
EudraGMDP
481923-104145903
GMP certificate
Competent authority of Austria5 Jun 2024
within 3-year review window
EudraGMDP
480012-103717782
GMP certificate
Competent authority of Austria17 Nov 2023
within 3-year review window
EudraGMDP
481921-103506902
GMP certificate
Competent authority of Austria17 Nov 2023
within 3-year review window
EudraGMDP
480012-104086651
GMP certificate
Competent authority of Austria17 Nov 2023
within 3-year review window
EudraGMDP
481921-103885483
GMP certificate
Competent authority of Austria17 Nov 2023
within 3-year review window
EudraGMDP
481921-101581881
GMP certificate
Competent authority of Austria17 Nov 2023
within 3-year review window
EudraGMDP
481921-102345473
GMP certificate
Competent authority of Austria17 Nov 2023
within 3-year review window
EudraGMDP
481921-103741277
GMP certificate
Competent authority of Austria17 Nov 2023
within 3-year review window
EudraGMDP
480012-103670929
GMP certificate
Competent authority of Austria17 Nov 2023
within 3-year review window
EudraGMDP
481921-103362902
GMP certificate
Competent authority of Austria17 Nov 2023
within 3-year review window
EudraGMDP
480012-100918750
GMP certificate
Competent authority of Austria17 Nov 2023
within 3-year review window
EudraGMDP
481922-101500981
GMP certificate
Competent authority of Austria23 Jun 2022
outside 3-year review window
EudraGMDP
481922-100622084
GMP certificate
Competent authority of Austria23 Jun 2022
outside 3-year review window
EudraGMDP
481922-101174956
GMP certificate
Competent authority of Austria23 Jun 2022
outside 3-year review window
EudraGMDP
481921-101430534
GMP certificate
Competent authority of Austria29 Mar 2022
outside 3-year review window
EudraGMDP
481921-100965639
GMP certificate
Competent authority of Austria29 Mar 2022
outside 3-year review window
EudraGMDP
481921-10213970
GMP certificate
Competent authority of AUSTRIA29 Mar 2022
outside 3-year review window
EudraGMDP
481921-101777235
GMP certificate
Competent authority of Austria29 Mar 2022
outside 3-year review window
EudraGMDP
481921-102130970
GMP certificate
Competent authority of Austria29 Mar 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