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 V, Sy. No.: 439, 440, 441 & 458, TSIIC Formulation SEZ, Polepally Village, Mahabubnagar, Telangana 509301, India (IND)
- Operations here
- manufacture
- FDA identifiers
- FEI 3008307735 · DUNS 650452530
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2022-08-12
- OAIDrug Quality Assurance2016-12-16
- NAIDrug Quality Assurance2015-05-01
- VAIDrug Quality Assurance2013-05-24
- NAIDrug Quality Assurance2010-11-19
Drugs this plant is listed as making
40 distinct drugs across 125 products name this site in their FDA label.
- Aamlodipine and Olmesartan MedoxomilCamber Pharmaceuticals, Inc.
- ABACAVIR and LAMIVUDINECamber Pharmaceuticals, Inc.
- AcyclovirCamber Pharmaceuticals, Inc.
- AllopurinolCamber Pharmaceuticals, Inc.
- Amlodipine and Olmesartan MedoxomilCamber Pharmaceuticals, Inc.
- AripiprazoleCamber Pharmaceuticals, Inc.
- Atorvastatin CalciumCamber Pharmaceuticals, Inc.
- capecitabineCamber Pharmaceuticals, Inc.
- Donepezil hydrochlorideQuallent Pharmaceuticals Health LLC
- EntecavirCamber Pharmaceuticals, Inc.
- ErlotinibCamber Pharmaceuticals, Inc.
- Eslicarbazepine acetateCamber Pharmaceuticals, Inc.
- Imatinib MesylateCamber Pharmaceuticals, Inc.
- IrbesartanCamber Pharmaceuticals, Inc.
- LamivudineCamber Pharmaceuticals, Inc.
- LAMIVUDINE and ZIDOVUDINECamber Pharmaceuticals, Inc.
- LenalidomideCamber Pharmaceuticals, Inc.
- LevofloxacinCamber Pharmaceuticals, Inc.
- LinezolidCamber Pharmaceuticals, Inc.
- Losartan PotassiumCamber Pharmaceuticals, Inc.
- Losartan Potassium And HydrochlorothiazideCamber Pharmaceuticals, Inc.
- Milnacipran HydrochlorideCamber Pharmaceuticals, Inc.
- MontelukastQuallent Pharmaceuticals Health LLC
- montelukast sodiumCamber Pharmaceuticals, Inc.
- MoxifloxacinCamber Pharmaceuticals, Inc.
- Mycophenolate MofetilCamber Pharmaceuticals, Inc.
- NilotinibCamber Pharmaceuticals, Inc.
- Olmesartan MedoxomilCamber Pharmaceuticals, Inc.
- Olmesartan medoxomil and hydrochlorothiazideCamber Pharmaceuticals, Inc.
- Olmesartan medoxomil, amlodipine and hydrochlorothiazideCamber Pharmaceuticals, Inc.
- PomalidomideCamber Pharmaceuticals, Inc.
- Quetiapine FumarateCamber Pharmaceuticals, Inc.
- SildenafilCamber Pharmaceuticals, Inc.
- TemozolomideCamber Pharmaceuticals, Inc.
- TetrabenazineCamber Pharmaceuticals, Inc.
- ValacyclovirCamber Pharmaceuticals, Inc.
- ValganciclovirCamber Pharmaceuticals, Inc.
- ValsartanCamber 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.