Suppliers / Sintenovo SA de CV

Sintenovo SA de CV

Mexico Updated 9 July 2026

Sintenovo SA de CV is an API manufacturer based in Mexico. It holds one active US drug master file and one valid CEP across a filed portfolio of 5 molecules. Its GMP standing is certified by COFEPRIS (MX).

1
active US DMFs
1
valid CEPs
4
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
Barcelona, Spain Not on file
Mexico, Mexico 3008725935
Jiutepec, Mexico Not on file
Jiutepec, Mexico Not on file

What they file, and where

Molecule Regulators Docs
Etamsylate SFDA (Saudi Arabia) 1
Omeprazole EDQM 1
Paliperidone US FDA 1
Sitagliptin SFDA (Saudi Arabia) 1
Sunitinib SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Paliperidone API Sunitinib API Omeprazole API Sitagliptin API

Filings and GMP by regulator

Regulator Filings GMP certificates
COFEPRIS (MX) None 2

Questions about Sintenovo SA de CV

Does Sintenovo SA de CV hold a US DMF or a CEP?
Sintenovo SA de CV 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.
Is Sintenovo SA de CV FDA-registered?
One site operated by Sintenovo SA de CV 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 Sintenovo SA de CV manufacture?
4 registered sites are on record, in Spain and Mexico (Barcelona, Mexico and Jiutepec among others). Every site is listed on this page with the register it came from.
What does Sintenovo SA de CV make?
5 molecules are on record against Sintenovo SA de CV, including Etamsylate, Omeprazole, Paliperidone and Sitagliptin. Each links through to that molecule's full manufacturer list.
Which regulators recognise Sintenovo SA de CV's GMP?
Current GMP certificates are on record from COFEPRIS (MX). 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