F. Hoffmann-La Roche AG

Kaiseraugst, SwitzerlandFEI 3003973536API manufacture registered

F. Hoffmann-La Roche AG is a drug establishment in Kaiseraugst, Switzerland, registered with the US FDA under FEI 3003973536. Its registered operations are: Analytical testing, API manufacture, Labelling, Drug manufacture, Packaging. 55 EU/UK GMP certificates are matched to this site, 34 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 manufacturePackaging

GMP documents matched to this site (55)

DocumentAuthorityInspectionSource
GMPEI-CH-1008408
GMP certificate
Competent authority of Switzerland6 Nov 2025
within 3-year review window
EudraGMDP
GMPEI-CH-1008798
GMP certificate
Competent authority of Switzerland6 Nov 2025
within 3-year review window
EudraGMDP
GMPEI-CH-1008413
GMP certificate
Competent authority of Switzerland6 Nov 2025
within 3-year review window
EudraGMDP
GMPEI-CH-1008805
GMP certificate
Competent authority of Switzerland6 Nov 2025
within 3-year review window
EudraGMDP
GMPEI-CH-1008018
GMP certificate
Competent authority of Switzerland6 Nov 2025
within 3-year review window
EudraGMDP
GMPEI-CH-1008051
GMP certificate
Competent authority of Switzerland6 Nov 2025
within 3-year review window
EudraGMDP
GMPEI-CH-1008416
GMP certificate
Competent authority of Switzerland21 Mar 2025
within 3-year review window
EudraGMDP
GMPEHV-CH-1007801
GMP certificate
Competent authority of Switzerland21 Mar 2025
within 3-year review window
EudraGMDP
GMPEHV-CH-1007676
GMP certificate
Competent authority of Switzerland21 Mar 2025
within 3-year review window
EudraGMDP
GMPEI-CH-1008796
GMP certificate
Competent authority of Switzerland21 Mar 2025
within 3-year review window
EudraGMDP
GMPEHV-CH-1008808
GMP certificate
Competent authority of Switzerland21 Mar 2025
within 3-year review window
EudraGMDP
GMPEI-CH-1007801
GMP certificate
Competent authority of Switzerland21 Mar 2025
within 3-year review window
EudraGMDP
GMPEHV-CH-1007273
GMP certificate
Competent authority of Switzerland21 Mar 2025
within 3-year review window
EudraGMDP
GMPEHV-CH-1008793
GMP certificate
Competent authority of Switzerland21 Mar 2025
within 3-year review window
EudraGMDP
GMPEI-CH-1008808
GMP certificate
Competent authority of Switzerland21 Mar 2025
within 3-year review window
EudraGMDP
GMPEI-CH-1008793
GMP certificate
Competent authority of Switzerland21 Mar 2025
within 3-year review window
EudraGMDP
GMPEHV-CH-1008406
GMP certificate
Competent authority of Switzerland21 Mar 2025
within 3-year review window
EudraGMDP
GMPEI-CH-1007676
GMP certificate
Competent authority of Switzerland21 Mar 2025
within 3-year review window
EudraGMDP
GMPEHV-CH-1008416
GMP certificate
Competent authority of Switzerland21 Mar 2025
within 3-year review window
EudraGMDP
GMPEI-CH-1007273
GMP certificate
Competent authority of Switzerland21 Mar 2025
within 3-year review window
EudraGMDP
GMPEI-CH-1007588
GMP certificate
Competent authority of Switzerland21 Mar 2025
within 3-year review window
EudraGMDP
GMPEHV-CH-1007638
GMP certificate
Competent authority of Switzerland21 Mar 2025
within 3-year review window
EudraGMDP
GMPEI-CH-1007638
GMP certificate
Competent authority of Switzerland21 Mar 2025
within 3-year review window
EudraGMDP
GMPEHV-CH-1007588
GMP certificate
Competent authority of Switzerland21 Mar 2025
within 3-year review window
EudraGMDP
GMPEI-CH-1008406
GMP certificate
Competent authority of Switzerland21 Mar 2025
within 3-year review window
EudraGMDP
GMPEHV-CH-1008796
GMP certificate
Competent authority of Switzerland21 Mar 2025
within 3-year review window
EudraGMDP
GMPEHV-CH-1007666
GMP certificate
Competent authority of Switzerland21 Mar 2025
within 3-year review window
EudraGMDP
GMPEI-CH-1007666
GMP certificate
Competent authority of Switzerland21 Mar 2025
within 3-year review window
EudraGMDP
GMPEHV-CH-1005823
GMP certificate
Competent authority of Switzerland30 Nov 2023
within 3-year review window
EudraGMDP
GMPEHV-CH-1006039
GMP certificate
Competent authority of Switzerland30 Nov 2023
within 3-year review window
EudraGMDP
GMPEI-CH-1005823
GMP certificate
Competent authority of Switzerland30 Nov 2023
within 3-year review window
EudraGMDP
GMPEHV-CH-1006282
GMP certificate
Competent authority of Switzerland30 Nov 2023
within 3-year review window
EudraGMDP
GMPEI-CH-1006282
GMP certificate
Competent authority of Switzerland30 Nov 2023
within 3-year review window
EudraGMDP
GMPEI-CH-1006039
GMP certificate
Competent authority of Switzerland30 Nov 2023
within 3-year review window
EudraGMDP
GMPEHV-CH-1005074
GMP certificate
Competent authority of Switzerland31 Mar 2023
outside 3-year review window
EudraGMDP
GMPEI-CH-1006404
GMP certificate
Competent authority of Switzerland31 Mar 2023
outside 3-year review window
EudraGMDP
GMPEI-CH-1004918
GMP certificate
Competent authority of Switzerland31 Mar 2023
outside 3-year review window
EudraGMDP
GMPEI-CH-1005074
GMP certificate
Competent authority of Switzerland31 Mar 2023
outside 3-year review window
EudraGMDP
GMPEI-CH-1006213
GMP certificate
Competent authority of Switzerland31 Mar 2023
outside 3-year review window
EudraGMDP
GMPEI-CH-1004781
GMP certificate
Competent authority of SWITZERLAND12 Apr 2022
outside 3-year review window
EudraGMDP
GMPEI-CH-1004919
GMP certificate
Competent authority of Switzerland12 Apr 2022
outside 3-year review window
EudraGMDP
GMPEI-CH-1004391
GMP certificate
Competent authority of Switzerland12 Apr 2022
outside 3-year review window
EudraGMDP
GMPEI-CH-1005636
GMP certificate
Competent authority of Switzerland12 Apr 2022
outside 3-year review window
EudraGMDP
GMPEI-CH-1007590
GMP certificate
Competent authority of Switzerland12 Apr 2022
outside 3-year review window
EudraGMDP
GMPEI-CH-1007668
GMP certificate
Competent authority of Switzerland12 Apr 2022
outside 3-year review window
EudraGMDP
GMPEI-CH-1006284
GMP certificate
Competent authority of Switzerland12 Apr 2022
outside 3-year review window
EudraGMDP
GMPEI-CH-1006210
GMP certificate
Competent authority of Switzerland12 Apr 2022
outside 3-year review window
EudraGMDP
GMPEI-CH-1007033
GMP certificate
Competent authority of Switzerland12 Apr 2022
outside 3-year review window
EudraGMDP
GMPEI-CH-1006041
GMP certificate
Competent authority of Switzerland12 Apr 2022
outside 3-year review window
EudraGMDP
GMPEI-CH-1007803
GMP certificate
Competent authority of Switzerland12 Apr 2022
outside 3-year review window
EudraGMDP
GMPEI-CH-1006401
GMP certificate
Competent authority of Switzerland12 Apr 2022
outside 3-year review window
EudraGMDP
GMPEI-CH-1004389
GMP certificate
Competent authority of SWITZERLAND25 Nov 2021
outside 3-year review window
EudraGMDP
GMPEHV-CH-1004389
GMP certificate
Competent authority of SWITZERLAND25 Nov 2021
outside 3-year review window
EudraGMDP
GMPEI-CH-1007673
GMP certificate
Competent authority of Switzerland13 Jul 2021
outside 3-year review window
EudraGMDP
GMPEI-CH-1007540
GMP certificate
Competent authority of Switzerland13 Jul 2021
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