Suppliers / Itf Chemical Ltda

Itf Chemical Ltda

Brazil Updated 9 July 2026

Itf Chemical Ltda is an API manufacturer based in Brazil. It holds 5 active US drug master files across a filed portfolio of 5 molecules. Its most recent recorded inspection, by US FDA, closed on 9 September 2022 as NAI.

5
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
1
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
5 of 5 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 9 September 2022 NAI US FDA
  • 8 December 2016 VAI US FDA
  • 28 March 2014 VAI US FDA
  • 4 August 2011 NAI US FDA
  • 13 November 2008 VAI 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 3004447173

What they file, and where

Molecule Regulators Docs
Azacitidine US FDA 1
Decitabine US FDA 1
Levofloxacin US FDA 1
Rosiglitazone US FDA 1
Temozolomide US FDA 1

Also appears on these molecule pages

Azacitidine API Decitabine API Levofloxacin API Temozolomide API

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 1 None

Questions about Itf Chemical Ltda

Does Itf Chemical Ltda hold a US DMF or a CEP?
Itf Chemical Ltda holds 5 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 Itf Chemical Ltda FDA-registered?
One site operated by Itf Chemical Ltda 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 Itf Chemical Ltda's last inspection go?
The most recent inspection on record closed on 9 September 2022 as NAI (No Action Indicated: nothing objectionable was found). 5 inspections are on file.
Where does Itf Chemical Ltda 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 Itf Chemical Ltda make?
5 molecules are on record against Itf Chemical Ltda, including Azacitidine, Decitabine, Levofloxacin and Rosiglitazone. Each links through to that molecule's full manufacturer list.
Where does Itf Chemical Ltda file?
Filings are on record with MINSA (CR), 1 in total.

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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Open risk flags

  • The most recent inspection outcome was NAI, on 9 September 2022.

Comparable suppliers

Hetero shares 3 molecules Dr Reddy's Laboratories shares 3 molecules Shilpa Pharma Lifesciences shares 3 molecules Reliance Life Sciences shares 3 molecules MSN Laboratories shares 2 molecules

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