Olpha is an API and finished-dose manufacturer based in Latvia. It holds 4 active US drug master files across a filed portfolio of 4 molecules. Its filings concentrate with AIFA (IT), AEMPS (ES) and EMA. Its GMP standing is certified by EAEU_EEC, UZPHARM (UZ) and US FDA, among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 10 June 2024 as NAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Latvia, Latvia | 3001672072 |
| Molecule | Regulators | Docs |
|---|---|---|
| Amantadine | US FDA | 1 |
| Anagrelide | US FDA | 1 |
| Memantine | US FDA | 1 |
| Rimantadine | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| AIFA (IT) | 203 | None |
| AEMPS (ES) | 65 | None |
| EMA | 45 | 1 |
| UZPHARM (UZ) | 7 | 1 |
| MHRA (UK) | 7 | None |
| MPA (SE) | 6 | None |
| EAEU_EEC | None | 1 |
| US FDA | None | 1 |
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