Luye Pharma is a finished-dose manufacturer based in Germany. It appears in 104 regulatory filings across 12 regulators, without an active US DMF or CEP on file. Its filings concentrate with MHRA (UK), EMA and HSA (SG). Its GMP standing is certified by ZLG (DE), HSA (SG) and MHRA (UK), among 5 authorities.
| Site | FDA FEI |
|---|---|
| Miesbach, United Arab Emirates | Not on file |
| MIESBACH, Germany | Not on file |
| Miesbach, Germany | Not on file |
| GUILDFORD, United Kingdom | Not on file |
| Regulator | Filings | GMP certificates |
|---|---|---|
| MHRA (UK) | 33 | 2 |
| EMA | 13 | 1 |
| HSA (SG) | 12 | 2 |
| SFDA (Saudi Arabia) | 10 | None |
| DH (HK) | 10 | None |
| NPRA (MY) | 7 | None |
| ZLG (DE) | None | 6 |
| EAEU_EEC | None | 1 |
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