Suppliers / Duke Chem S.A.U

Duke Chem S.A.U

Spain Updated 9 July 2026

Duke Chem S.A.U is an API manufacturer based in Spain. It holds one active US drug master file and one valid CEP across a filed portfolio of 2 molecules.

1
active US DMFs
1
valid CEPs
1
registered plants
1
filings across 1 regulators

Registered plants

Site FDA FEI
S.A.U. Olérdola, Spain Not on file

What they file, and where

Molecule Regulators Docs
Brinzolamide US FDA 1
Etofenamate EDQM 1

Also appears on these molecule pages

Brinzolamide API

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 1 None

Questions about Duke Chem S.A.U

Does Duke Chem S.A.U hold a US DMF or a CEP?
Duke Chem S.A.U holds 1 active US drug master file and 1 valid CEP. 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 Duke Chem S.A.U manufacture?
1 registered site is on record, in Spain (S.a.u. Olérdola). Every site is listed on this page with the register it came from.
What does Duke Chem S.A.U make?
2 molecules are on record against Duke Chem S.A.U, including Brinzolamide and Etofenamate. Each links through to that molecule's full manufacturer list.
Where does Duke Chem S.A.U file?
Filings are on record with MINSA (CR), 1 in total.

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