Suppliers / Novartis Pharma Produktions

Novartis Pharma Produktions

Germany 2 duplicate records merged Updated 9 July 2026

Novartis Pharma Produktions is a finished-dose manufacturer based in Germany. It appears in 40 regulatory filings across 5 regulators, without an active US DMF or CEP on file. Its filings concentrate with DIGEMAPS (DO), ARCSA (EC) and NPRA (MY). Its GMP standing is certified by ZLG (DE), ANVISA (Brazil) and MFDS (Korea), among 6 authorities. Its most recent recorded inspection, by US FDA, closed on 11 July 2024 as VAI.

0
active US DMFs
0
valid CEPs
4
registered plants 1 with an FDA FEI number
40
filings across 5 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
6 of 6 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

  • 11 July 2024 VAI US FDA
  • 27 September 2019 NAI US FDA
  • 19 May 2017 NAI US FDA
  • 18 June 2015 NAI US FDA
  • 24 June 2013 NAI US FDA
  • 15 September 2011 VAI US FDA

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

Registered plants

Site FDA FEI
WEHR/BADEN, Germany Not on file
Wehr, Germany Not on file
Germany, Germany 3000978864
Baden-Wuerttemberg, Germany Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
DIGEMAPS (DO) 16 None
ARCSA (EC) 11 None
NPRA (MY) 7 None
NAFDAC (NG) 3 None
MINSA (CR) 3 None
ZLG (DE) None 4
ANVISA (Brazil) None 3
MFDS (Korea) None 2
NCELS (KZ) None 1
US FDA None 1
EMA None 1

Questions about Novartis Pharma Produktions

Does Novartis Pharma Produktions hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Novartis Pharma Produktions. It does have 40 filings with 5 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Novartis Pharma Produktions FDA-registered?
One site operated by Novartis Pharma Produktions 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 Produktions's last inspection go?
The most recent inspection on record closed on 11 July 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 6 inspections are on file.
Where does Novartis Pharma Produktions manufacture?
4 registered sites are on record, in Germany (Wehr/baden, Wehr and Germany among others). Every site is listed on this page with the register it came from.
Which regulators recognise Novartis Pharma Produktions's GMP?
Current GMP certificates are on record from ZLG (DE), ANVISA (Brazil), MFDS (Korea), NCELS (KZ), US FDA and 1 more. 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 11 July 2024.

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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