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Manufacturing facility

Aurobindo Pharma 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
Unit-XII, Sy.No.314, Bachupally, Bachupally Mandal, Medchal-Malkajgiri District, Medchal, Telangana 500090, India (IND)
Operations here
analysismanufacture
FDA identifiers
FEI 3004446312 · DUNS 918917683

Recent inspection flagged official action

FDA classified an inspection here as OAI (official action indicated) within the last two years — the strongest public warning signal a facility gets. This plant is listed on labels for 11 drugs. A supply problem here can ripple to all of them.

FDA inspection history

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

  • OAIDrug Quality Assurance2025-09-05
  • VAIDrug Quality Assurance2023-03-09
  • VAIDrug Quality Assurance2020-02-21
  • VAIDrug Quality Assurance2018-03-16
  • NAIDrug Quality Assurance2013-08-16
  • VAIDrug Quality Assurance2012-06-26
  • VAIDrug Quality Assurance2010-09-17
  • VAIDrug Quality Assurance2009-04-09

Drugs this plant is listed as making

11 distinct drugs across 60 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.