Suppliers / Novartis Manufacturing

Novartis Manufacturing

United States Updated 9 July 2026

Novartis Manufacturing is a finished-dose manufacturer based in United States. It appears in 14 regulatory filings across 3 regulators, without an active US DMF or CEP on file. Its filings concentrate with ARCSA (EC), NCELS (KZ) and MINSA (CR). Its GMP standing is certified by ANVISA (Brazil), MFDS (Korea) and US FDA. Its most recent recorded inspection, by US FDA, closed on 5 March 2025 as VAI.

0
active US DMFs
0
valid CEPs
6
registered plants 3 with an FDA FEI number
14
filings across 3 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
3 of 3 confirmed
Inspections
6 of 6 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 5 March 2025 VAI US FDA
  • 29 April 2021 VAI US FDA
  • 9 November 2018 VAI US FDA
  • 15 November 2016 VAI US FDA
  • 26 March 2014 NAI US FDA
  • 29 January 2010 NAI US FDA

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

Registered plants

Site FDA FEI
Puurs-Sint-Amands, United Arab Emirates Not on file
PUURS-SINT-AMANDS, Belgium Not on file
Belgium, Belgium 3002037047
INDIANAPOLIS, United States Not on file
Indianapolis, United States 3019881323
Carlsbad, United States 3013510604

Filings and GMP by regulator

Regulator Filings GMP certificates
ARCSA (EC) 9 None
NCELS (KZ) 4 None
MINSA (CR) 1 None
ANVISA (Brazil) None 2
MFDS (Korea) None 2
US FDA None 1

Questions about Novartis Manufacturing

Does Novartis Manufacturing hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Novartis Manufacturing. It does have 14 filings with 3 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Novartis Manufacturing FDA-registered?
3 sites operated by Novartis Manufacturing carry an FDA establishment identifier (FEI), which means they are registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Novartis Manufacturing's last inspection go?
The most recent inspection on record closed on 5 March 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 6 inspections are on file.
Where does Novartis Manufacturing manufacture?
6 registered sites are on record, in United Arab Emirates, Belgium and United States (Puurs-sint-amands, Puurs-sint-amands and Belgium among others). Every site is listed on this page with the register it came from.
Which regulators recognise Novartis Manufacturing's GMP?
Current GMP certificates are on record from ANVISA (Brazil), MFDS (Korea) and US FDA. 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 5 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