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

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

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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