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