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

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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