Suppliers / Novartis Pharma Schweizerhalle

Novartis Pharma Schweizerhalle

Switzerland Updated 9 July 2026

Novartis Pharma Schweizerhalle is a finished-dose manufacturer based in Switzerland. It appears in 4 regulatory filings across 1 regulator, without an active US DMF or CEP on file. Its GMP standing is certified by EMA, US FDA and ANVISA (Brazil). Its most recent recorded inspection, by US FDA, closed on 27 March 2025 as VAI.

0
active US DMFs
0
valid CEPs
2
registered plants 1 with an FDA FEI number
4
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
7 of 7 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

  • 27 March 2025 VAI US FDA
  • 25 August 2022 NAI US FDA
  • 23 June 2017 VAI US FDA
  • 14 July 2015 NAI US FDA
  • 25 September 2012 NAI US FDA
  • 9 July 2010 VAI US FDA
  • 10 September 2009 NAI US FDA

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

Registered plants

Site FDA FEI
PRATTELN, Switzerland Not on file
Switzerland, Switzerland 3002865753

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 4 None
EMA None 2
US FDA None 1
ANVISA (Brazil) None 1

Questions about Novartis Pharma Schweizerhalle

Does Novartis Pharma Schweizerhalle hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Novartis Pharma Schweizerhalle. It does have 4 filings with one regulator, so it is registered, just not with the two strong registers buyers usually screen on.
Is Novartis Pharma Schweizerhalle FDA-registered?
One site operated by Novartis Pharma Schweizerhalle 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 Schweizerhalle's last inspection go?
The most recent inspection on record closed on 27 March 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 7 inspections are on file.
Where does Novartis Pharma Schweizerhalle manufacture?
2 registered sites are on record, in Switzerland (Pratteln and Switzerland). Every site is listed on this page with the register it came from.
Which regulators recognise Novartis Pharma Schweizerhalle's GMP?
Current GMP certificates are on record from EMA, US FDA and ANVISA (Brazil). 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 27 March 2025.

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Sources on this page

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