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-3, Sy. No: 410/P, 411/P and 458/P, Plot No. S-1/B, Pharma SEZ, TSIIC, Polepally (Village), Jadcherla (Mandal), Mahabubnagar (District), Mahabubnagar, Telangana 509302, India (IND)
- Operations here
- analysismanufacture
- FDA identifiers
- FEI 3011255967 · DUNS 878100017
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
12 distinct drugs across 15 products name this site in their FDA label.
- Betamethasone DipropionateAurobindo Pharma Limited
- Clindamycin Phosphatein shortageAurobindo Pharma Limited
- Clobetasol PropionateAurobindo Pharma Limited
- DapsoneAurobindo Pharma Limited
- Econazole NitrateAurobindo Pharma Limited
- LidocaineAurobindo Pharma Limited
- Metronidazolein shortageAurobindo Pharma Limited
- NystatinAurobindo Pharma Limited
- PermethrinAurobindo Pharma Limited
- TretinoinAurobindo 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.