Chr. Olesen Synthesis A/S is an API manufacturer based in Denmark. It holds 2 active US drug master files and 7 valid CEPs across a filed portfolio of 7 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 22 November 2023 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Hvidovre, Denmark | Not on file |
| Denmark, Denmark | 3006358320 |
| Molecule | Regulators | Docs |
|---|---|---|
| Buprenorphine | EDQM, US FDA | 3 |
| Dexamfetamine Sulfate | EDQM | 1 |
| Hydromorphone | EDQM | 1 |
| Pramipexole | US FDA | 1 |
| Pramipexole Dihydrochloride | EDQM | 1 |
| Terbinafine | EDQM | 1 |
| Tolfenamic Acid | EDQM | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| US FDA | None | 1 |
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