Suppliers / Novartis Pharma Stein

Novartis Pharma Stein

Switzerland 2 duplicate records merged Updated 9 July 2026

Novartis Pharma Stein is a finished-dose manufacturer based in Switzerland. It appears in 87 regulatory filings across 9 regulators, without an active US DMF or CEP on file. Its filings concentrate with ARCSA (EC), MINSA (CR) and NAFDAC (NG). Its GMP standing is certified by EMA, ANVISA (Brazil) and EAEU_EEC, among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 6 December 2022 as VAI.

0
active US DMFs
0
valid CEPs
4
registered plants 1 with an FDA FEI number
87
filings across 9 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
8 of 8 confirmed
EU GMP
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Inspection history

  • 6 December 2022 VAI US FDA
  • 4 December 2018 VAI US FDA
  • 9 May 2017 VAI US FDA
  • 16 October 2015 VAI US FDA
  • 1 May 2015 NAI US FDA
  • 25 March 2014 NAI US FDA
  • 22 June 2012 VAI US FDA
  • 2 July 2010 VAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
STEIN, United Arab Emirates Not on file
STEIN, Switzerland Not on file
Switzerland, Switzerland 3002653483
Stein AG, Switzerland Not on file

What they file, and where

Molecule Regulators Docs
Diclofenac Diethylamine SFDA (Saudi Arabia) 1
Pasireotide Diaspartate SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Deferasirox finished dose Everolimus finished dose Siponimod finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
ARCSA (EC) 48 None
MINSA (CR) 13 None
NAFDAC (NG) 10 1
DIGEMAPS (DO) 8 None
NPRA (MY) 3 None
MCAZ (ZW) 2 None
EMA None 6
ANVISA (Brazil) None 2
EAEU_EEC None 1

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Open risk flags

  • The most recent inspection outcome was VAI, on 6 December 2022.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates