Suppliers / Roche Diagnostics

Roche Diagnostics

Germany 4 duplicate records merged Updated 9 July 2026

Roche Diagnostics is an API manufacturer based in Germany. It holds 2 valid CEPs across a filed portfolio of 2 molecules. Its filings concentrate with ARCSA (EC), NAFDAC (NG) and INVIMA (CO). Its GMP standing is certified by ZLG (DE), EMA and NAFDAC (NG).

0
active US DMFs
2
valid CEPs
10
registered plants
56
filings across 6 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
Mannheim, United Arab Emirates Not on file
D-68305 Mannheim, United Arab Emirates Not on file
Mannheim, United Arab Emirates Not on file
MANNHEIM, Germany Not on file
Penzberg, Germany Not on file
Baden-Wuerttemberg, Germany Not on file

4 further sites are on record.

What they file, and where

Molecule Regulators Docs
Digoxin EDQM 1
Doxepin EDQM 1

Also appears on these molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
ARCSA (EC) 23 None
NAFDAC (NG) 18 1
INVIMA (CO) 6 None
BOMRA (BW) 6 None
MINSA (CR) 2 None
SFDA (Saudi Arabia) 1 None
ZLG (DE) None 12
EMA None 3

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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