Suppliers / H. Lundbeck A/S

H. Lundbeck A/S

Denmark Updated 9 July 2026

H. Lundbeck A/S is an API and finished-dose manufacturer based in Denmark. 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

Amitriptyline finished dose Aripiprazole finished dose Brexpiprazole finished dose Citalopram API Escitalopram API Memantine finished dose Nortriptyline finished dose Rasagiline finished dose Vortioxetine finished dose

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 We do not publish the identity of any buyer.

Questions about H. Lundbeck A/S

Does H. Lundbeck A/S hold a US DMF or a CEP?
H. Lundbeck A/S holds 3 active US drug master files. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
Where does H. Lundbeck A/S manufacture?
5 registered sites are on record, in United Arab Emirates, Switzerland, Denmark and Mexico (Valby, Opfikon and Tlalnepantla among others). Every site is listed on this page with the register it came from.
What does H. Lundbeck A/S make?
4 molecules are on record against H. Lundbeck A/S, including Citalopram, Escitalopram, Escitalopram Base and Gaboxadol. Each links through to that molecule's full manufacturer list.
Which regulators recognise H. Lundbeck A/S's GMP?
Current GMP certificates are on record from MFDS (Korea), HSA (SG) and EMA. GMP recognition covers the manufacturing site, separately from any filing on the substance itself.

Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.

Comparing suppliers?

Choose your molecules and target markets. H. Lundbeck A/S comes back tiered against every other supplier able to file there.

Start for free
No sales call.

Comparable suppliers

Apitoria Pharma shares 2 molecules Hetero shares 2 molecules Cipla shares 2 molecules Dr Reddy's Laboratories shares 2 molecules Raks Pharma shares 2 molecules

Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

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