Suppliers / Gentec

Gentec

Spain Updated 9 July 2026

Gentec is an API manufacturer based in Spain. It holds 2 active US drug master files and one valid CEP across a filed portfolio of 2 molecules.

2
active US DMFs
1
valid CEPs
2
registered plants 1 with an FDA FEI number
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026.

Registered plants

Site FDA FEI
S.A. L´Hospitalet de Llobregat, Spain Not on file
Spain, Spain 3019432058

What they file, and where

Molecule Regulators Docs
Latanoprost EDQM, US FDA 2
Travoprost US FDA 1

Also appears on these molecule pages

Questions about Gentec

Does Gentec hold a US DMF or a CEP?
Gentec holds 2 active US drug master files 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.
Is Gentec FDA-registered?
One site operated by Gentec carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
Where does Gentec manufacture?
2 registered sites are on record, in Spain (S.a. L´hospitalet De Llobregat and Spain). Every site is listed on this page with the register it came from.
What does Gentec make?
2 molecules are on record against Gentec, including Latanoprost and Travoprost. Each links through to that molecule's full manufacturer list.

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