Suppliers / Anidro do Brasil Extracoes

Anidro do Brasil Extracoes

Brazil Updated 9 July 2026

Anidro do Brasil Extracoes is an API manufacturer based in Brazil. It holds one active US drug master file and 2 valid CEPs. Its GMP standing is certified by MHRA (UK) and US FDA. Its most recent recorded inspection, by US FDA, closed on 15 November 2024 as VAI.

1
active US DMFs
2
valid CEPs
3
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
5 of 5 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 15 November 2024 VAI US FDA
  • 25 October 2019 VAI US FDA
  • 14 December 2016 VAI US FDA
  • 20 September 2012 VAI US FDA
  • 13 May 2010 VAI US FDA

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

Registered plants

Site FDA FEI
Parnaíba, Brazil Not on file
BR-64216 815, Brazil Not on file
Brazil, Brazil 3002807563

What they file, and where

Molecule Regulators Docs
Pilocarpine EDQM, US FDA 3

Filings and GMP by regulator

Regulator Filings GMP certificates
MHRA (UK) None 2
US FDA None 1

Questions about Anidro do Brasil Extracoes

Does Anidro do Brasil Extracoes hold a US DMF or a CEP?
Anidro do Brasil Extracoes holds 1 active US drug master file and 2 valid CEPs. 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 Anidro do Brasil Extracoes FDA-registered?
One site operated by Anidro do Brasil Extracoes 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 Anidro do Brasil Extracoes's last inspection go?
The most recent inspection on record closed on 15 November 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 5 inspections are on file.
Where does Anidro do Brasil Extracoes manufacture?
3 registered sites are on record, in Brazil (Parnaíba, Br-64216 815 and Brazil). Every site is listed on this page with the register it came from.
What does Anidro do Brasil Extracoes make?
1 molecule is on record against Anidro do Brasil Extracoes, including Pilocarpine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Anidro do Brasil Extracoes's GMP?
Current GMP certificates are on record from MHRA (UK) and 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.

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Open risk flags

  • The most recent inspection outcome was VAI, on 15 November 2024.

Comparable suppliers

Sourcetech Quimica Ltda also in Brazil Nortec Quimica also in Brazil Pfizer Brasil Ltda also in Brazil Itf Chemical Ltda also in Brazil Janssen-Cilag Farmaceutica Ltda also in Brazil

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