Suppliers / Roche Diagnostics

Roche Diagnostics

Germany 4 duplicate records merged Updated 9 July 2026

Roche Diagnostics 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 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
Baden-Wuerttemberg, Germany Not on file
Penzberg, 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

Digoxin API Doxepin API Ozanimod finished dose Vincristine finished dose

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

Questions about Roche Diagnostics

Does Roche Diagnostics hold a US DMF or a CEP?
Roche Diagnostics 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 Roche Diagnostics manufacture?
10 registered sites are on record, in United Arab Emirates, Germany, Nigeria and Norway (Mannheim, D-68305 Mannheim and Mannheim among others). Every site is listed on this page with the register it came from.
What does Roche Diagnostics make?
2 molecules are on record against Roche Diagnostics, including Digoxin and Doxepin. Each links through to that molecule's full manufacturer list.
Which regulators recognise Roche Diagnostics's GMP?
Current GMP certificates are on record from ZLG (DE), EMA and NAFDAC (NG). 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