Apl Healthcare 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. 410/P, 411/P, 458/P, Plot No. S-1/B, TSIIC SEZ, Green Industrial Park, Polepally (Village), Jadcherla (Mandal), Mahabubnagar (District), Mahabubnagar, Telangana 509302, India (IND)
- Operations here
- analysismanufacture
- FDA identifiers
- FEI 3011255967 · DUNS 650844777
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- NAIDrug Quality Assurance2023-01-18
- VAIDrug Quality Assurance2017-03-31
Drugs this plant is listed as making
41 distinct drugs across 102 products name this site in their FDA label.
- BaclofenAurobindo Pharma Limited
- CarvedilolAurobindo Pharma Limited
- Cevimeline HydrochlorideAurobindo Pharma Limited
- ChlorzoxazoneAurobindo Pharma Limited
- CimetidineAurobindo Pharma Limited
- Clomipramine HydrochlorideAurobindo Pharma Limited
- Clorazepate DipotassiumAurolife Pharma LLC
- ColchicineAurobindo Pharma Limited
- Diclofenac PotassiumAurobindo Pharma Limited
- Dicyclomine HydrochlorideAurobindo Pharma Limited
- doxazosin mesylateAurobindo Pharma Limited
- FamotidineAurobindo Pharma Limited
- FlucytosineAurobindo Pharma Limited
- FluoxetineAurobindo Pharma Limited
- Fluphenazine HydrochlorideAurobindo Pharma Limited
- Furosemidein shortageAurobindo Pharma Limited
- GabapentinAurobindo Pharma Limited
- Guanfacine HydrochlorideAurobindo Pharma Limited
- Hydroxychloroquine SulfateAurobindo Pharma Limited
- Hydroxyzine HydrochlorideAurobindo Pharma Limited
- IbuprofenAurobindo Pharma Limited
- LevofloxacinAurobindo Pharma Limited
- Losartan Potassium and HydrochlorothiazideAurobindo Pharma Limited
- Minocycline HydrochlorideAurobindo Pharma Limited
- ModafinilAurobindo Pharma Limited
- ParicalcitolAurobindo Pharma Limited
- Phenoxybenzamine HydrochlorideAurobindo Pharma Limited
- polyethylene glyocol 3350, sodium chloride, sodium bicarbonate and potassium chlorideAurobindo Pharma Limited
- PyrimethamineAurobindo Pharma Limited
- Quinapril Hydrochloridein shortageAurobindo Pharma Limited
- Sulfamethoxazole and TrimethoprimCronus Pharma LLC
- UrsodiolAurobindo Pharma Limited
- ZafirlukastAurobindo Pharma Limited
- ZonisamideAurobindo Pharma Limited
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.