Suppliers / Nortec Quimica

Nortec Quimica

Brazil Updated 9 July 2026

Nortec Quimica is an API manufacturer based in Brazil. It holds 4 active US drug master files across a filed portfolio of 5 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 4 August 2023 as VAI.

4
active US DMFs
0
valid CEPs
1
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
Inspections
3 of 3 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 4 August 2023 VAI US FDA
  • 22 July 2022 OAI US FDA
  • 8 December 2016 NAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
Brazil, Brazil 3007616930

What they file, and where

Molecule Regulators Docs
Prilocaine SFDA (Saudi Arabia), US FDA 4
Bupivacaine US FDA 1
Esketamine US FDA 1
Mepivacaine SFDA (Saudi Arabia) 1
Spironolactone US FDA 1

Also appears on these molecule pages

Bupivacaine API Esketamine API Mepivacaine API Prilocaine API Spironolactone API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

Questions about Nortec Quimica

Does Nortec Quimica hold a US DMF or a CEP?
Nortec Quimica holds 4 active US drug master files. 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 Nortec Quimica FDA-registered?
One site operated by Nortec Quimica 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.
How did Nortec Quimica's last inspection go?
The most recent inspection on record closed on 4 August 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 3 inspections are on file, of which 1 closed as OAI.
Where does Nortec Quimica manufacture?
1 registered site is on record, in Brazil (Brazil). Every site is listed on this page with the register it came from.
What does Nortec Quimica make?
5 molecules are on record against Nortec Quimica, including Prilocaine, Bupivacaine, Esketamine and Mepivacaine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Nortec Quimica's GMP?
Current GMP certificates are on record from US FDA. 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.

Comparing suppliers?

Choose your molecules and target markets. Nortec Quimica comes back tiered against every other supplier able to file there.

Start for free
No sales call.

Open risk flags

  • The most recent inspection outcome was VAI, on 4 August 2023.

Comparable suppliers

Moehs shares 3 molecules Societa Italiana Medicinali Scandicci Sims shares 2 molecules Apex Healthcare shares 2 molecules Maithri Drugs shares 1 molecule EUROAPI shares 1 molecule

Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates