Is SINTENOVO SA DE CV FDA approved?

SINTENOVO SA DE CV holds 1 FDA-registered establishment in Mexico. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.

Where are SINTENOVO SA DE CV's drugs manufactured?

The FDA register lists Jiutepec. Registered operations: analytical testing, active ingredient (API) manufacture.

What drugs does SINTENOVO SA DE CV make?

2 products are listed under SINTENOVO SA DE CV in the openFDA NDC Directory, most often as powder. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

SINTENOVO SA DE CV

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 1
Active NDC listings: 2
Live patents: 0
Countries: 1
Base: Mexico

Authorisation

Registered operations

Analytical testing1Active ingredient (API) manufacture1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
SINTENOVO S.A. DE C.V.Registrant: SINTENOVO SA DE CV	Calle 13 Este, No. 3, CIVAC, Jiutepec, Morelos 62578, Mexico (MEX)	Analytical testing, Active ingredient (API) manufacture	3008725935812039808

Catalogue

Drug listings by form and route

2 active NDC listings: 2 bulk ingredient. By marketing category: BULK INGREDIENT 1, BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING 1.

Dosage form	NDCs
powder	2

Route	NDCs

Labeller name on the listing	NDCs
sintenovo sa de cv	2

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	Paliperidone	powder	61730-0008BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
-	Roflumilast	powder	61730-0010BULK INGREDIENT

Neighbours

Registered in the same town

Vantive US Healthcare LLCJiutepec, MEX
Degasa, S.A. de C.V.Jiutepec, MEX
Laboratorios Imperiales, S.A. de C.V.Jiutepec, MEX

Compare

Comparable companies in Mexico

Sicor de Mexico S.A. de C.V.1 site · 27 NDC
Avon Cosmetics Manufacturing, S. de R.L. de C.V.1 site · 16 NDC
Holiday Labs Mexico, S.A. de C.V.1 site · 15 NDC
Interquim, S.A. de C.V.1 site · 14 NDC
Bayer de Mexico, S.A. de C.V.1 site · 10 NDC
Signa S.A. de C.V.1 site · 9 NDC
Nouryon Chemicals, S.A. de C.V1 site · 8 NDC
Laboratorios Imperiales, S.A. de C.V.1 site · 7 NDC
Laboratorios Zeyco SA de CV1 site · 5 NDC
Fermic, S.A. de C.V.1 site · 4 NDC

Enquiry

Common questions

Is SINTENOVO SA DE CV FDA approved?: SINTENOVO SA DE CV holds 1 FDA-registered establishment in Mexico. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
Where are SINTENOVO SA DE CV's drugs manufactured?: The FDA register lists Jiutepec. Registered operations: analytical testing, active ingredient (API) manufacture.
What drugs does SINTENOVO SA DE CV make?: 2 products are listed under SINTENOVO SA DE CV in the openFDA NDC Directory, most often as powder. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.