Genzyme is a finished-dose manufacturer based in United States. It appears in 1,528 regulatory filings across 30 regulators, without an active US DMF or CEP on file. Its filings concentrate with MHRA (UK), INFARMED (PT) and TITCK (TR). Its GMP standing is certified by MFDS (Korea), MHRA (UK) and ANVISA (Brazil), among 9 authorities. Its most recent recorded inspection, by US FDA, closed on 14 August 2025 as NAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Waterford, United Arab Emirates | Not on file |
| Northborough, United Arab Emirates | Not on file |
| Scoppito, United Arab Emirates | Not on file |
| Scoppito, United Arab Emirates | Not on file |
| Anagni, United Arab Emirates | Not on file |
| Marcy-L'Etoile, France | Not on file |
6 further sites are on record.
| Molecule | Regulators | Docs |
|---|---|---|
| Sevelamer Carbonate | SFDA (Saudi Arabia) | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| MHRA (UK) | 376 | 4 |
| INFARMED (PT) | 207 | None |
| TITCK (TR) | 191 | None |
| EDA (EG) | 180 | None |
| Health Canada | 118 | None |
| FAMHP (BE) | 69 | None |
| MFDS (Korea) | None | 8 |
| ANVISA (Brazil) | None | 2 |
| EAEU_EEC | None | 2 |
| ANSM (FR) | None | 1 |
| US FDA | None | 1 |
| EMA | None | 1 |
| HSA (SG) | None | 1 |
| NAFDAC (NG) | None | 1 |
| Year | Revenue | Exports | Destinations |
|---|---|---|---|
| 2024 | $4.0B | Not reported | Not reported |
| 2020 | $0 | 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 We do not publish the identity of any buyer.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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