Novartis is an API and finished-dose manufacturer based in Switzerland. It holds 10 active US drug master files and 3 valid CEPs across a filed portfolio of 12 molecules. Its filings concentrate with Health Canada, MHRA (UK) and US FDA. Its GMP standing is certified by ZLG (DE), ANSM (FR) and EMA, among 11 authorities. Its most recent recorded inspection, by US FDA, closed on 27 January 2026 as NAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Torre Annunziata, United Arab Emirates | Not on file |
| Torre Annunziata (NA), United Arab Emirates | Not on file |
| STEIN, United Arab Emirates | Not on file |
| North carolina, United Arab Emirates | Not on file |
| Nuremberg, United Arab Emirates | Not on file |
| Langkampfen, United Arab Emirates | Not on file |
6 further sites are on record.
| Molecule | Regulators | Docs |
|---|---|---|
| Amlodipine | EDQM, US FDA | 2 |
| Sirolimus | US FDA | 2 |
| Valsartan | EDQM, US FDA | 2 |
| Ferric Carboxymaltose | SFDA (Saudi Arabia) | 1 |
| Fluvastatin | US FDA | 1 |
| Indacaterol | SFDA (Saudi Arabia) | 1 |
| Letrozole | EDQM | 1 |
| Mycophenolic Acid | US FDA | 1 |
| Naftifine | US FDA | 1 |
| Pentetreotide | US FDA | 1 |
| Terbinafine | US FDA | 1 |
| Topotecan | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| Health Canada | 718 | None |
| MHRA (UK) | 432 | 6 |
| US FDA | 396 | 5 |
| SWISSMEDIC (CH) | 290 | None |
| AIFA (IT) | 286 | None |
| DH (HK) | 206 | None |
| ZLG (DE) | None | 28 |
| ANSM (FR) | None | 26 |
| EMA | None | 23 |
| ANVISA (Brazil) | None | 12 |
| MFDS (Korea) | None | 10 |
| EAEU_EEC | None | 7 |
| NAFDAC (NG) | None | 6 |
| NCELS (KZ) | None | 2 |
| EDA (EG) | None | 1 |
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