Suppliers / F.Hoffmann-La Roche

F.Hoffmann-La Roche

Switzerland 6 duplicate records merged Updated 9 July 2026

F.Hoffmann-La Roche is a finished-dose manufacturer based in Switzerland. It appears in 310 regulatory filings across 11 regulators, without an active US DMF or CEP on file. Its filings concentrate with DAV (Vietnam), RAMA (GE) and ARCSA (EC). Its GMP standing is certified by EMA, TMDA (TZ) and NAFDAC (NG).

0
active US DMFs
0
valid CEPs
6
registered plants
310
filings across 11 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
Kaiseraugst, United Arab Emirates Not on file
Kaiseraugst, United Arab Emirates Not on file
Basel, United Arab Emirates Not on file
KAISERAUGST, Switzerland Not on file
Kaiseraugst, Switzerland Not on file
Basel, Switzerland Not on file

What they file, and where

Molecule Regulators Docs
Cobimetinib Hemifumarate SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Alectinib finished dose Baloxavir Marboxil finished dose Benserazide finished dose Capecitabine finished dose Erlotinib finished dose Flumazenil finished dose Ganciclovir finished dose Ibandronate finished dose Ibandronic Acid finished dose Orlistat finished dose Valganciclovir finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
DAV (Vietnam) 147 None
RAMA (GE) 52 None
ARCSA (EC) 25 None
MINSA (CR) 25 None
SFDA (Saudi Arabia) 14 None
EFDA (ET) 13 None
EMA None 18
TMDA (TZ) None 2
NAFDAC (NG) None 1

Questions about F.Hoffmann-La Roche

Does F.Hoffmann-La Roche hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for F.Hoffmann-La Roche. It does have 310 filings with 11 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Where does F.Hoffmann-La Roche manufacture?
6 registered sites are on record, in United Arab Emirates and Switzerland (Kaiseraugst, Basel and Kaiseraugst among others). Every site is listed on this page with the register it came from.
What does F.Hoffmann-La Roche make?
1 molecule is on record against F.Hoffmann-La Roche, including Cobimetinib Hemifumarate. Each links through to that molecule's full manufacturer list.
Which regulators recognise F.Hoffmann-La Roche's GMP?
Current GMP certificates are on record from EMA, TMDA (TZ) 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