Bachem is an API manufacturer based in Switzerland. It holds 20 active US drug master files and 6 valid CEPs across a filed portfolio of 24 molecules. Its filings concentrate with MINSA (CR) and INVIMA (CO). Its GMP standing is certified by US FDA and EMA. Its most recent recorded inspection, by US FDA, closed on 16 August 2024 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Bubendorf, Switzerland | Not on file |
| Switzerland, Switzerland | 1000153019 |
| Switzerland, Switzerland | 3002808225 |
| Molecule | Regulators | Docs |
|---|---|---|
| Goserelin | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Octreotide | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Propofol | SFDA (Saudi Arabia), US FDA | 4 |
| Leuprolide | EDQM, SFDA (Saudi Arabia), US FDA | 3 |
| Atosiban | SFDA (Saudi Arabia) | 2 |
| Bivalirudin | SFDA (Saudi Arabia), US FDA | 2 |
| Glucagon | US FDA | 2 |
| Gonadorelin | EDQM, US FDA | 2 |
| Icatibant | SFDA (Saudi Arabia), US FDA | 2 |
| Triptorelin | SFDA (Saudi Arabia), US FDA | 2 |
| Aminolevulinic Acid | US FDA | 1 |
| Antazoline | SFDA (Saudi Arabia) | 1 |
| Calcitonin (Salmon) | EDQM | 1 |
| Carbidopa | US FDA | 1 |
| Eteplirsen | SFDA (Saudi Arabia) | 1 |
| Etomidate | US FDA | 1 |
| Glucagon Synthetic | SFDA (Saudi Arabia) | 1 |
| Histrelin | US FDA | 1 |
| Liraglutide | US FDA | 1 |
| Pegcetacoplan | SFDA (Saudi Arabia) | 1 |
| Semaglutide | US FDA | 1 |
| Sincalide | US FDA | 1 |
| Somatostatin | EDQM | 1 |
| Tetracosactide | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| MINSA (CR) | 2 | None |
| INVIMA (CO) | 1 | None |
| US FDA | None | 2 |
| EMA | None | 2 |
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