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 VI, Sy. No.: 410 & 411, TSIIC Formulation SEZ, Polepally Village, Jadcherla Mandal,, Mahabubnagar, Telangana 509301, India (IND)
- Operations here
- manufacture
- FDA identifiers
- FEI 3008294355 · DUNS 650452548
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2023-09-21
- OAIDrug Quality Assurance2016-11-15
- VAIDrug Quality Assurance2013-05-23
Drugs this plant is listed as making
7 distinct drugs across 10 products name this site in their FDA label.
- Azacitidinein shortageCamber Pharmaceuticals, Inc.
- BortezomibCamber Pharmaceuticals, Inc.
- DecitabineCamber Pharmaceuticals, Inc.
- Melphalan HydrochlorideCamber Pharmaceuticals, Inc.
- OxaliplatinCamber Pharmaceuticals, Inc.
- Pemetrexed disodiumCamber Pharmaceuticals, Inc.
- PlerixaforCamber Pharmaceuticals, 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.