Piramal Critical Care is a finished-dose manufacturer based in United States. It holds one active US drug master file across a filed portfolio of 3 molecules. Its filings concentrate with EMA, AIFA (IT) and FAMHP (BE). Its GMP standing is certified by MHRA (UK), MFDS (Korea) and US FDA. Its most recent recorded inspection, by US FDA, closed on 27 September 2023 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Bethlehem, United Arab Emirates | Not on file |
| Rüschlikon, Switzerland | Not on file |
| WEST DRAYTON, United Kingdom | Not on file |
| Bethlehem, United States | 1000135935 |
| Molecule | Regulators | Docs |
|---|---|---|
| Desflurane | US FDA | 1 |
| Isoflurane | SFDA (Saudi Arabia) | 1 |
| Sevoflurane | SFDA (Saudi Arabia) | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| EMA | 70 | None |
| AIFA (IT) | 39 | None |
| FAMHP (BE) | 22 | None |
| MPA (SE) | 18 | None |
| URPL (PL) | 17 | None |
| MHRA (UK) | 15 | 4 |
| MFDS (Korea) | None | 2 |
| US FDA | None | 1 |
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