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Manufacturing facility

Apotex Research Private Limited

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
India
Registered address
Plot No.1 And 2, Bommasandra Industrial Area, 4th Phase, Jigani Link Road, Bengaluru, Karnataka 560099, India (IND)
Operations here
analysismanufacture
FDA identifiers
FEI 3006076314 · DUNS 862584104

FDA inspection history

Outcomes of closed FDA inspections at this site (drug and biologic program areas).

  • VAIDrug Quality Assurance2024-03-15
  • NAIBioresearch Monitoring2019-02-02
  • VAIDrug Quality Assurance2016-05-20
  • OAIDrug Quality Assurance2014-07-01
  • VAIDrug Quality Assurance2013-07-12
  • VAIDrug Quality Assurance2012-06-22
  • VAIDrug Quality Assurance2010-04-17

Drugs this plant is listed as making

1 distinct drugs across 2 products name this site in their FDA label.

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.