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Manufacturing facility

Hetero Labs 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 III, Plot No. 22-110, Part-II, IDA, Jeedimetla, Hyderabad, Telangana 500055, India (IND)
Operations here
manufacture
FDA identifiers
FEI 3005406526 · DUNS 676162024

FDA inspection history

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

  • VAIDrug Quality Assurance2023-07-21
  • VAIDrug Quality Assurance2019-06-07
  • NAIDrug Quality Assurance2018-03-23
  • VAIDrug Quality Assurance2016-10-26
  • VAIDrug Quality Assurance2015-07-31
  • VAIDrug Quality Assurance2013-10-11
  • VAIDrug Quality Assurance2011-12-15
  • VAIDrug Quality Assurance2009-11-02

Drugs this plant is listed as making

70 distinct drugs across 184 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.