Suppliers / Antibioticos Do Brasil Ltda

Antibioticos Do Brasil Ltda

Brazil 39 employees Updated 9 July 2026

Antibioticos Do Brasil Ltda is an API and finished-dose manufacturer based in Brazil. It holds 5 active US drug master files and one valid CEP across a filed portfolio of 7 molecules. Its filings concentrate with ANVISA (Brazil), COFEPRIS (MX) and ARCSA (EC). Its GMP standing is certified by ANVISA (Brazil), EMA and COFEPRIS (MX), among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 27 May 2022 as NAI.

5
active US DMFs
1
valid CEPs
8
registered plants 1 with an FDA FEI number
166
filings across 5 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
6 of 6 confirmed
EU GMP
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Inspection history

  • 27 May 2022 NAI US FDA
  • 28 August 2018 OAI US FDA
  • 27 April 2016 OAI US FDA
  • 26 February 2013 VAI US FDA
  • 18 March 2010 VAI US FDA
  • 6 November 2008 OAI US FDA

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

Registered plants

Site FDA FEI
COSMOPOLIS, Brazil Not on file
Brazil, Brazil 3004132818
SUMARÉ, Brazil Not on file
Cosmopolis Sao Paulo, Brasil, Colombia Not on file
Iztapalapa, Mexico Not on file
Coyoacán, Mexico Not on file

2 further sites are on record.

What they file, and where

Molecule Regulators Docs
Cefepime SFDA (Saudi Arabia), US FDA 2
Amoxicillin US FDA 1
Ampicillin US FDA 1
Arginine US FDA 1
Ceftazidime Pentahydrate With Sodium Carbonate For Injection EDQM 1
Ceftobiprole Medocaril Sodium SFDA (Saudi Arabia) 1
Cephalexin US FDA 1

Also appears on these molecule pages

Amoxicillin API Ampicillin API Arginine API Azithromycin finished dose Cabergoline finished dose Captopril finished dose Cefalotin finished dose Cefazolin finished dose Cefepime API Ceftazidime finished dose Cephalexin API Clarithromycin finished dose
Show 22 more molecule pages
Colistin finished dose Daptomycin finished dose Dexmedetomidine finished dose Dobutamine finished dose Ertapenem finished dose Etomidate finished dose Felodipine finished dose Fentanyl finished dose Hydrocortisone finished dose Irinotecan finished dose Linezolid finished dose Meropenem finished dose Metronidazole finished dose Polymyxin B finished dose Rocuronium finished dose Teicoplanin finished dose Tirofiban finished dose Tobramycin finished dose Travoprost finished dose Vancomycin finished dose Vincristine finished dose Zoledronic Acid finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
ANVISA (Brazil) 137 6
COFEPRIS (MX) 9 2
ARCSA (EC) 8 None
INVIMA (CO) 7 1
DIGEMAPS (DO) 5 None
EMA None 4

Questions about Antibioticos Do Brasil Ltda

Does Antibioticos Do Brasil Ltda hold a US DMF or a CEP?
Antibioticos Do Brasil Ltda holds 5 active US drug master files and 1 valid CEP. 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 Antibioticos Do Brasil Ltda FDA-registered?
One site operated by Antibioticos Do Brasil 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 Antibioticos Do Brasil Ltda's last inspection go?
The most recent inspection on record closed on 27 May 2022 as NAI (No Action Indicated: nothing objectionable was found). 6 inspections are on file, of which 3 closed as OAI.
Where does Antibioticos Do Brasil Ltda manufacture?
8 registered sites are on record, in Brazil, Colombia and Mexico (Cosmopolis, Brazil and Sumaré among others). Every site is listed on this page with the register it came from.
What does Antibioticos Do Brasil Ltda make?
7 molecules are on record against Antibioticos Do Brasil Ltda, including Cefepime, Amoxicillin, Ampicillin and Arginine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Antibioticos Do Brasil Ltda's GMP?
Current GMP certificates are on record from ANVISA (Brazil), EMA, COFEPRIS (MX) and INVIMA (CO). 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

  • 1 active litigation matter is on record.
  • The most recent inspection outcome was NAI, on 27 May 2022.

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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