Suppliers / H. Lundbeck A/S

H. Lundbeck A/S

Mexico Updated 9 July 2026

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.

3
active US DMFs
0
valid CEPs
5
registered plants
986
filings across 34 regulators
These figures were checked against the regulators' own files on 25 July 2026
EU GMP
1 of 1 confirmed
Sources: EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Registered plants

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

What they file, and where

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

Filings and GMP by regulator

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

Scale

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 We do not publish the identity of any buyer.

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Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates
Customs aggregates
Export values, molecule and destination counts