Suppliers / Dr. Willmar Schwabe GmbH

Dr. Willmar Schwabe GmbH

Germany 2 duplicate records merged Updated 9 July 2026

Dr. Willmar Schwabe GmbH is an API and finished-dose manufacturer based in Germany. It holds 2 active US drug master files across a filed portfolio of 2 molecules. Its filings concentrate with EMA, AIFA (IT) and MPA (SE). Its GMP standing is certified by ZLG (DE), ANVISA (Brazil) and EMA, among 5 authorities.

2
active US DMFs
0
valid CEPs
4
registered plants
201
filings across 12 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
KARLSRUHE, Germany Not on file
Baden-Wuerttemberg, Germany Not on file
Imt Rohtak, India Not on file
Guadalajara, Mexico Not on file

What they file, and where

Molecule Regulators Docs
Colchicine US FDA 1
Thiocolchicoside US FDA 1

Also appears on these molecule pages

Colchicine API Methionine finished dose Thiocolchicoside API

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA 89 2
AIFA (IT) 45 None
MPA (SE) 17 None
FAMHP (BE) 14 None
AEMPS (ES) 11 None
INFARMED (PT) 5 None
ZLG (DE) None 6
ANVISA (Brazil) None 3
CDSCO (India) None 2
COFEPRIS (MX) None 2

Questions about Dr. Willmar Schwabe GmbH

Does Dr. Willmar Schwabe GmbH hold a US DMF or a CEP?
Dr. Willmar Schwabe GmbH holds 2 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 Dr. Willmar Schwabe GmbH manufacture?
4 registered sites are on record, in Germany, India and Mexico (Karlsruhe, Baden-wuerttemberg and Imt Rohtak among others). Every site is listed on this page with the register it came from.
What does Dr. Willmar Schwabe GmbH make?
2 molecules are on record against Dr. Willmar Schwabe GmbH, including Colchicine and Thiocolchicoside. Each links through to that molecule's full manufacturer list.
Which regulators recognise Dr. Willmar Schwabe GmbH's GMP?
Current GMP certificates are on record from ZLG (DE), ANVISA (Brazil), EMA, CDSCO (India) and COFEPRIS (MX). 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