Mylan Dublin is a finished-dose manufacturer based in India. It holds 2 active US drug master files across a filed portfolio of 2 molecules. Its filings concentrate with US FDA, JFDA (JO) and MCAZ (ZW). Its GMP standing is certified by CDSCO (India) and MHRA (UK).
| Site | FDA FEI |
|---|---|
| Bangalore- 562105, United Arab Emirates | Not on file |
| Bangalore 562105, United Arab Emirates | Not on file |
| DUBLIN, Ireland | Not on file |
| BANGALORE, India | Not on file |
| Hosur –, India | Not on file |
| hosur 635 130, India | Not on file |
6 further sites are on record.
| Molecule | Regulators | Docs |
|---|---|---|
| Fomepizole | US FDA | 1 |
| Isosulfan Blue | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| US FDA | 546 | None |
| JFDA (JO) | 9 | None |
| MCAZ (ZW) | 2 | None |
| EDE (AE) | 1 | None |
| CDSCO (India) | None | 10 |
| MHRA (UK) | None | 2 |
Choose your molecules and target markets. Mylan Dublin comes back tiered against every other supplier able to file there.
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