Antibioticos do Brasil Ltda
A single plant registered with the FDA to make drugs for the US market. Below is where it is and the drugs whose FDA labels list this site as performing a manufacturing step — so if this plant has a problem, these are the products that could be affected.
- Country
- Brazil
- Registered address
- Rod SP-332 KM 135 Itapavussu, Cosmópolis, SP 13151-350, Brazil (BRA)
- Operations here
- api manufacturemanufacture
- FDA identifiers
- FEI 3004132818 · DUNS 907154959
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- NAIDrug Quality Assurance2022-05-27
- OAIDrug Quality Assurance2018-08-28
- OAIDrug Quality Assurance2016-04-27
- VAIDrug Quality Assurance2013-02-26
- VAIDrug Quality Assurance2010-03-18
- OAIDrug Quality Assurance2008-11-06
Drugs this plant is listed as making
1 distinct drugs across 2 products name this site in their FDA label.
- CefepimeFresenius Kabi USA, LLC
Sources:the establishment's name, address, and country from FDA's Drug Establishments Current Registration Site (DECRS); the drug-to-facility links from DailyMed SPL drug labels, matched by the facility's DUNS number; inspection outcomes from the FDA Data Dashboard, matched by FEI; shortage status from FDA's drug shortage database. More on how this is built. Educational only.