Macfarlan Smith is an API manufacturer based in United Kingdom. It holds 4 active US drug master files and 20 valid CEPs across a filed portfolio of 17 molecules. Its GMP standing is certified by MHRA (UK). Its most recent recorded inspection, by US FDA, closed on 29 November 2021 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Annan, United Kingdom | Not on file |
| Edinburgh, United Kingdom | Not on file |
| United Kingdom, United Kingdom | 3002807530 |
| Molecule | Regulators | Docs |
|---|---|---|
| Fentanyl | EDQM, SFDA (Saudi Arabia) | 4 |
| Apomorphine | EDQM, SFDA (Saudi Arabia), US FDA | 3 |
| Buprenorphine | EDQM, US FDA | 3 |
| Morphine | EDQM, SFDA (Saudi Arabia) | 3 |
| Naloxone | EDQM, SFDA (Saudi Arabia), US FDA | 3 |
| Codeine | EDQM | 2 |
| Methadone | EDQM, SFDA (Saudi Arabia) | 2 |
| Naltrexone | EDQM, US FDA | 2 |
| Oxycodone | EDQM, SFDA (Saudi Arabia) | 2 |
| Alfentanil | EDQM | 1 |
| Cocaine | EDQM | 1 |
| Dihydrocodeine | EDQM | 1 |
| Hydromorphone | EDQM | 1 |
| Methylphenidate | EDQM | 1 |
| Morphine Hemisulfate 2.5-Hydrate | EDQM | 1 |
| Remifentanil | EDQM | 1 |
| Sufentanil | EDQM | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| MINSA (CR) | 1 | None |
| MHRA (UK) | None | 2 |
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