Novartis Pharma Stein AG

Stein, SwitzerlandFEI 3002653483API manufacture registered

Novartis Pharma Stein AG is a drug establishment in Stein, Switzerland, registered with the US FDA under FEI 3002653483. Its registered operations are: Analytical testing, API manufacture, Labelling, Drug manufacture, Packaging. 48 EU/UK GMP certificates are matched to this site, 37 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 (48)

DocumentAuthorityInspectionSource
GMPE-CH-1008505
GMP certificate
Competent authority of Switzerland17 Dec 2025
within 3-year review window
EudraGMDP
GMPE-CH-1008346
GMP certificate
Competent authority of Switzerland17 Dec 2025
within 3-year review window
EudraGMDP
GMPE-CH-1008345
GMP certificate
Competent authority of Switzerland17 Dec 2025
within 3-year review window
EudraGMDP
GMPEI-CH-1006665
GMP certificate
Competent authority of Switzerland19 Jul 2024
within 3-year review window
EudraGMDP
GMPEHV-CH-1007816
GMP certificate
Competent authority of Switzerland19 Jul 2024
within 3-year review window
EudraGMDP
GMPEHV-CH-1007043
GMP certificate
Competent authority of Switzerland19 Jul 2024
within 3-year review window
EudraGMDP
GMPEHV-CH-1006665
GMP certificate
Competent authority of Switzerland19 Jul 2024
within 3-year review window
EudraGMDP
GMPEI-CH-1007816
GMP certificate
Competent authority of Switzerland19 Jul 2024
within 3-year review window
EudraGMDP
GMPEHV-CH-1008318
GMP certificate
Competent authority of Switzerland19 Jul 2024
within 3-year review window
EudraGMDP
GMPEI-CH-1008318
GMP certificate
Competent authority of Switzerland19 Jul 2024
within 3-year review window
EudraGMDP
GMPEHV-CH-1006420
GMP certificate
Competent authority of Switzerland19 Jul 2024
within 3-year review window
EudraGMDP
GMPEI-CH-1007043
GMP certificate
Competent authority of Switzerland19 Jul 2024
within 3-year review window
EudraGMDP
GMPEI-CH-1006420
GMP certificate
Competent authority of Switzerland19 Jul 2024
within 3-year review window
EudraGMDP
GMPE-CH-1006186
GMP certificate
Competent authority of Switzerland1 Jul 2024
within 3-year review window
EudraGMDP
GMPE-CH-1006664
GMP certificate
Competent authority of Switzerland1 Jul 2024
within 3-year review window
EudraGMDP
GMPE-CH-1007042
GMP certificate
Competent authority of Switzerland1 Jul 2024
within 3-year review window
EudraGMDP
GMPE-CH-1007815
GMP certificate
Competent authority of Switzerland1 Jul 2024
within 3-year review window
EudraGMDP
GMPE-CH-1008319
GMP certificate
Competent authority of Switzerland28 Mar 2024
within 3-year review window
EudraGMDP
GMPE-CH-1006347
GMP certificate
Competent authority of Switzerland28 Mar 2024
within 3-year review window
EudraGMDP
GMPE-CH-1007817
GMP certificate
Competent authority of Switzerland28 Mar 2024
within 3-year review window
EudraGMDP
GMPE-CH-1007818
GMP certificate
Competent authority of Switzerland28 Mar 2024
within 3-year review window
EudraGMDP
GMPE-CH-1007821
GMP certificate
Competent authority of Switzerland28 Mar 2024
within 3-year review window
EudraGMDP
GMPEI-CH-1006348
GMP certificate
Competent authority of Switzerland28 Mar 2024
within 3-year review window
EudraGMDP
GMPEHV-CH-1006349
GMP certificate
Competent authority of Switzerland28 Mar 2024
within 3-year review window
EudraGMDP
GMPE-CH-1007045
GMP certificate
Competent authority of Switzerland28 Mar 2024
within 3-year review window
EudraGMDP
GMPE-CH-1006666
GMP certificate
Competent authority of Switzerland28 Mar 2024
within 3-year review window
EudraGMDP
GMPEHV-CH-1006667
GMP certificate
Competent authority of Switzerland28 Mar 2024
within 3-year review window
EudraGMDP
GMPE-CH-1008160
GMP certificate
Competent authority of Switzerland28 Mar 2024
within 3-year review window
EudraGMDP
GMPEHV-CH-1006348
GMP certificate
Competent authority of Switzerland28 Mar 2024
within 3-year review window
EudraGMDP
GMPE-CH-1007044
GMP certificate
Competent authority of Switzerland28 Mar 2024
within 3-year review window
EudraGMDP
GMPE-CH-1008506
GMP certificate
Competent authority of Switzerland28 Mar 2024
within 3-year review window
EudraGMDP
GMPE-CH-1008159
GMP certificate
Competent authority of Switzerland17 Jan 2024
within 3-year review window
EudraGMDP
GMPE-CH-1005628
GMP certificate
Competent authority of Switzerland17 Jan 2024
within 3-year review window
EudraGMDP
GMPE-CH-1007820
GMP certificate
Competent authority of Switzerland17 Jan 2024
within 3-year review window
EudraGMDP
GMPE-CH-1005557
GMP certificate
Competent authority of Switzerland17 Jan 2024
within 3-year review window
EudraGMDP
GMPEHV-CH-1005558
GMP certificate
Competent authority of Switzerland4 Jan 2024
within 3-year review window
EudraGMDP
GMPEI-CH-1005558
GMP certificate
Competent authority of Switzerland4 Jan 2024
within 3-year review window
EudraGMDP
GMPE-CH-1005314
GMP certificate
Competent authority of SWITZERLAND10 Dec 2021
outside 3-year review window
EudraGMDP
GMPEHV-CH-1005317
GMP certificate
Competent authority of Switzerland26 Nov 2021
outside 3-year review window
EudraGMDP
GMPEHV-CH-1004941
GMP certificate
Competent authority of SWITZERLAND26 Nov 2021
outside 3-year review window
EudraGMDP
GMPE-CH-1004880
GMP certificate
Competent authority of SWITZERLAND26 Nov 2021
outside 3-year review window
EudraGMDP
GMPEI-CH-1004943
GMP certificate
Competent authority of SWITZERLAND16 Jun 2021
outside 3-year review window
EudraGMDP
GMPEHV-CH-1004943
GMP certificate
Competent authority of SWITZERLAND16 Jun 2021
outside 3-year review window
EudraGMDP
GMPEHV-CH-1005315
GMP certificate
Competent authority of Switzerland16 Jun 2021
outside 3-year review window
EudraGMDP
GMPEI-CH-1005315
GMP certificate
Competent authority of Switzerland16 Jun 2021
outside 3-year review window
EudraGMDP
GMPE-CH-1004944
GMP certificate
Competent authority of SWITZERLAND19 May 2021
outside 3-year review window
EudraGMDP
GMPE-CH-1005316
GMP certificate
Competent authority of Switzerland19 May 2021
outside 3-year review window
EudraGMDP
GMPEHV-CH-1004881
GMP certificate
Competent authority of SWITZERLAND20 Apr 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.

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