Suppliers / Grünenthal

Grünenthal

Germany Updated 9 July 2026

Grünenthal is an API and finished-dose manufacturer based in Germany. It holds 2 valid CEPs across a filed portfolio of 2 molecules. Its filings concentrate with AIFA (IT), INFARMED (PT) and EMA. Its GMP standing is certified by ANVISA (Brazil).

0
active US DMFs
2
valid CEPs
11
registered plants
1,428
filings across 16 regulators

Registered plants

Site FDA FEI
Aachen, United Arab Emirates Not on file
AACHEN, Germany Not on file
Aachen, Germany Not on file
SAN BORJA, Peru Not on file
SAN BORJA, Peru Not on file
SAN BORJA, Peru Not on file

5 further sites are on record.

What they file, and where

Molecule Regulators Docs
Betahistine Dihydrochloride EDQM 1
Tapentadol EDQM 1

Also appears on these molecule pages

Betahistine contract manufacturing Calci contract manufacturing Capsaicin finished dose Clarithromycin finished dose Esomeprazole finished dose Fentanyl finished dose Gatifloxacin finished dose Granisetron finished dose Nevirapine finished dose Rifaximin finished dose Tapentadol API Testosterone Undecanoate finished dose
Show 3 more molecule pages
Thiocolchicoside finished dose Tramadol contract manufacturing Zolmitriptan finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
AIFA (IT) 724 None
INFARMED (PT) 146 None
EMA 104 None
MHRA (UK) 102 None
MPA (SE) 91 None
FAMHP (BE) 76 None
ANVISA (Brazil) None 4

Questions about Grünenthal

Does Grünenthal hold a US DMF or a CEP?
Grünenthal holds 2 valid CEPs. 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 Grünenthal manufacture?
11 registered sites are on record, in United Arab Emirates, Germany, Peru and Portugal (Aachen, Aachen and SAN Borja among others). Every site is listed on this page with the register it came from.
What does Grünenthal make?
2 molecules are on record against Grünenthal, including Betahistine Dihydrochloride and Tapentadol. Each links through to that molecule's full manufacturer list.
Which regulators recognise Grünenthal's GMP?
Current GMP certificates are on record from ANVISA (Brazil). 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.

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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