Lonza is an API manufacturer based in Switzerland. It holds 5 active US drug master files and 4 valid CEPs across a filed portfolio of 9 molecules. Its filings concentrate with ARCSA (EC), MINSA (CR) and INVIMA (CO). Its GMP standing is certified by EMA, MHRA (UK) and HSA (SG), among 7 authorities. Its most recent recorded inspection, by US FDA, closed on 6 February 2026 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Geleen, United Arab Emirates | Not on file |
| Braine-Lalleud, Belgium | Not on file |
| Braine-L'Alleud, Belgium | Not on file |
| Switzerland, Switzerland | 3016502617 |
| Switzerland, Switzerland | 3012793444 |
| Stein Ag, Switzerland | Not on file |
6 further sites are on record.
| Molecule | Regulators | Docs |
|---|---|---|
| Nicotinamide | EDQM, US FDA | 2 |
| Nicotinic Acid | EDQM | 2 |
| Desmopressin | EDQM | 1 |
| Dexmethylphenidate | US FDA | 1 |
| Fluvoxamine | US FDA | 1 |
| Macitentan | SFDA (Saudi Arabia) | 1 |
| Pomalidomide | SFDA (Saudi Arabia) | 1 |
| Sirolimus | US FDA | 1 |
| Voclosporin | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| ARCSA (EC) | 11 | None |
| MINSA (CR) | 4 | None |
| INVIMA (CO) | 4 | None |
| EEC_EAEU | 2 | None |
| EMA | None | 11 |
| MHRA (UK) | None | 7 |
| HSA (SG) | None | 2 |
| MFDS (Korea) | None | 2 |
| US FDA | None | 2 |
| ANVISA (Brazil) | None | 1 |
| AEMPS (ES) | None | 1 |
Choose your molecules and target markets. Lonza comes back tiered against every other supplier able to file there.
Start for free