H. Lundbeck A/S is an API and finished-dose manufacturer based in Mexico. It holds 3 active US drug master files across a filed portfolio of 4 molecules. Its filings concentrate with AIFA (IT), FAMHP (BE) and MPA (SE). Its GMP standing is certified by MFDS (Korea), HSA (SG) and EMA. Customs aggregates show $173 of exports covering 16 molecules to 1 destination in 2022.
| Site | FDA FEI |
|---|---|
| Valby, United Arab Emirates | Not on file |
| Opfikon, Switzerland | Not on file |
| Valby, Denmark | Not on file |
| Tlalnepantla, Mexico | Not on file |
| Riyadh, Saudi Arabia | Not on file |
| Molecule | Regulators | Docs |
|---|---|---|
| Citalopram | US FDA | 1 |
| Escitalopram | US FDA | 1 |
| Escitalopram Base | SFDA (Saudi Arabia) | 1 |
| Gaboxadol | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| AIFA (IT) | 169 | None |
| FAMHP (BE) | 119 | None |
| MPA (SE) | 101 | None |
| EMA | 74 | 1 |
| SWISSMEDIC (CH) | 58 | None |
| DKMA (DK) | 48 | None |
| MFDS (Korea) | None | 2 |
| HSA (SG) | None | 2 |
| Year | Revenue | Exports | Destinations |
|---|---|---|---|
| 2022 | Not reported | $173 | 1 |
Export figures are customs aggregates. We do not publish the identity of any buyer.
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