Baxalta Us is a finished-dose manufacturer based in United States. It appears in 1,362 regulatory filings across 33 regulators, without an active US DMF or CEP on file. Its filings concentrate with MHRA (UK), AIFA (IT) and EMA. Its GMP standing is certified by MFDS (Korea), ANVISA (Brazil) and ZLG (DE), among 6 authorities. Its most recent recorded inspection, by US FDA, closed on 7 November 2025 as NAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Linz, United Arab Emirates | Not on file |
| Singen, United Arab Emirates | Not on file |
| Oranienburg, United Arab Emirates | Not on file |
| Co. Wicklow, United Arab Emirates | Not on file |
| Dublin, United Arab Emirates | Not on file |
| Naucalpan De Juarez, Colombia | Not on file |
6 further sites are on record.
| Regulator | Filings | GMP certificates |
|---|---|---|
| MHRA (UK) | 389 | None |
| AIFA (IT) | 162 | None |
| EMA | 93 | None |
| INFARMED (PT) | 83 | None |
| TITCK (TR) | 73 | None |
| FAMHP (BE) | 69 | None |
| MFDS (Korea) | None | 4 |
| ANVISA (Brazil) | None | 3 |
| ZLG (DE) | None | 2 |
| COFEPRIS (MX) | None | 2 |
| US FDA | None | 2 |
| EAEU_EEC | None | 2 |
| Year | Revenue | Exports | Destinations |
|---|---|---|---|
| 2025 | $95.7M | Not reported | Not reported |
| 2023 | $450.0B | Not reported | Not reported |
| 2022 | $390.0B | Not reported | Not reported |
Export figures are customs aggregates. We do not publish the identity of any buyer. Revenue shown in US dollars, converted from the reported currency.
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