Is Nortec Quimica SA FDA approved?

Nortec Quimica SA holds 1 FDA-registered establishment in Brazil. 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 Nortec Quimica SA's drugs manufactured?

The FDA register lists Duque de Caxias. Registered operations: active ingredient (API) manufacture.

What drugs does Nortec Quimica SA make?

3 products are listed under Nortec Quimica SA 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.

Nortec Quimica SA

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

Request a quote Claim this profile

Registered sites: 1
Active NDC listings: 3
Labeller names: 2
Live patents: 0
Countries: 1
Base: Brazil

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Nortec Quimica SA	Rua Dezessete, 200 Distrito Industrial de Duque de Caxias, Duque de Caxias, Rio de Janeiro 25250612, Brazil (BRA)	Active ingredient (API) manufacture	3007616930899043087

Catalogue

Drug listings by form and route

3 active NDC listings: 3 bulk ingredient. By marketing category: BULK INGREDIENT 3.

Dosage form	NDCs
powder	3

Route	NDCs

Labeller name on the listing	NDCs
nortec quimica sa	2
nortec quimica s.a.	1

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	Bupivacaine	powder	59014-0053BULK INGREDIENT
-	Esketamine Hydrochloride	powder	59014-0020BULK INGREDIENT
-	Prilocaine	powder	59014-0052BULK INGREDIENT

Compare

Comparable companies in Brazil

Antibioticos do Brasil Ltda1 site · 3 NDC
Anidro Do Brasil Extracoes SA1 site · 1 NDC

Enquiry

Common questions

Is Nortec Quimica SA FDA approved?: Nortec Quimica SA holds 1 FDA-registered establishment in Brazil. 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 Nortec Quimica SA's drugs manufactured?: The FDA register lists Duque de Caxias. Registered operations: active ingredient (API) manufacture.
What drugs does Nortec Quimica SA make?: 3 products are listed under Nortec Quimica SA 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.