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

Questions about Novartis Pharma Stein

Does Novartis Pharma Stein hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Novartis Pharma Stein. It does have 87 filings with 9 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Novartis Pharma Stein FDA-registered?
One site operated by Novartis Pharma Stein carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Novartis Pharma Stein's last inspection go?
The most recent inspection on record closed on 6 December 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Novartis Pharma Stein manufacture?
4 registered sites are on record, in United Arab Emirates and Switzerland (Stein, Switzerland and Stein AG among others). Every site is listed on this page with the register it came from.
What does Novartis Pharma Stein make?
2 molecules are on record against Novartis Pharma Stein, including Diclofenac Diethylamine and Pasireotide Diaspartate. Each links through to that molecule's full manufacturer list.
Which regulators recognise Novartis Pharma Stein's GMP?
Current GMP certificates are on record from EMA, ANVISA (Brazil), EEC (Eurasian Economic Union) and NAFDAC (NG). GMP recognition covers the manufacturing site, separately from any filing on the substance itself.

Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.

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Open risk flags

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

Comparable suppliers

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Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

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