Hetero Drugs 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 I, Sy. No. 213, 214 & 255, Bonthapally Village, Gummadidala Mandal,, Sangareddy district, Telangana 502313, India (IND)
- Operations here
- api manufacture
- FDA identifiers
- FEI 3003510514 · DUNS 650433076
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2025-05-16
- VAIDrug Quality Assurance2020-02-14
- VAIDrug Quality Assurance2018-03-02
- NAIDrug Quality Assurance2016-02-25
- VAIDrug Quality Assurance2014-05-02
- NAIDrug Quality Assurance2010-11-11
Drugs this plant is listed as making
1 distinct drugs across 2 products name this site in their FDA label.
- TetrabenazineBionpharma Inc.
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.