Manufacturing facility
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-IV, Plot No.16, 16 – A, APIIC, M.P.Sez, Menakuru Village, Naidupeta Mandal, Tirupati District, Tirupati, Andhra Pradesh 524421, India (IND)
- Operations here
- analysismanufacture
- FDA identifiers
- FEI 3011895410 · DUNS 650918514
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2025-12-17
- VAIDrug Quality Assurance2020-02-28
- NAIDrug Quality Assurance2019-04-19
- NAIBioresearch Monitoring2019-03-20
- NAIDrug Quality Assurance2018-10-26
Drugs this plant is listed as making
92 distinct drugs across 303 products name this site in their FDA label.
- AcyclovirAurobindo Pharma Limited
- AlbuterolAurobindo Pharma Limited
- AllopurinolAurobindo Pharma Limited
- ambrisentanAurobindo Pharma Limited
- Amitriptyline HydrochlorideAurobindo Pharma Limited
- Amlodipine BesylateAurobindo Pharma Limited
- Azelastine HydrochlorideAurobindo Pharma Limited
- bumetanidein shortageRising Pharma Holdings, Inc
- Bupropion HydrochlorideAurobindo Pharma Limited
- Buspirone HydrochlorideAurobindo Pharma Limited
- CarbidopaNorthStar Rx LLC
- Carbidopa and LevodopaAurobindo Pharma Limited
- carisoprodolRising Pharma Holdings, Inc.
- Chlordiazepoxide Hydrochloride and Clidinium BromideAurobindo Pharma Limited
- Chlorpromazine HydrochlorideAurobindo Pharma Limited
- ClobazamAurobindo Pharma Limited
- Clonazepamin shortageAurobindo Pharma Limited
- Clonidine HydrochlorideAurobindo Pharma Limited
- ClozapineAurobindo Pharma Limited
- Dapagliflozin and Metformin hydrochlorideAurobindo Pharma Limited
- DarunavirAurobindo Pharma Limited
- DeferasiroxAurobindo Pharma Limited
- DiazepamAurobindo Pharma Limited
- Diclofenac SodiumAurobindo Pharma Limited
- DigoxinAurobindo Pharma Limited
- Dimethyl FumarateAurobindo Pharma Limited
- DofetilideAurobindo Pharma Limited
- DoxepinAurobindo Pharma Limited
- Doxepin HydrochlorideAurobindo Pharma Limited
- DroxidopaAurobindo Pharma Limited
- Eletriptan HydrobromideAurobindo Pharma Limited
- Emtricitabine and Tenofovir Disoproxil FumarateAurobindo Pharma Limited
- Enalapril MaleateAurobindo Pharma Limited
- Esomeprazole MagnesiumAurobindo Pharma Limited
- Ezetimibe and SimvastatinAurobindo Pharma Limited
- FebuxostatAurobindo Pharma Limited
- FenofibrateAurobindo Pharma Limited
- FluoxetineBluePoint Laboratories
- Fluoxetine HydrochlorideQuallent Pharmaceuticals Health Llc
- Fosfomycin tromethamineAurobindo Pharma Limited
- GabapentinAurobindo Pharma Limited
- GlycopyrrolateAurobindo Pharma Limited
- HaloperidolAurobindo Pharma Limited
- HydrocortisoneAurobindo Pharma Limited
- Ibuprofen OralAurobindo Pharma Limited
- Isosorbide MononitrateAurobindo Pharma Limited
- IsotretinoinAurobindo Pharma Limited
- LeflunomideAurobindo Pharma Limited
- LevetiracetamAurobindo Pharma Limited
- Levothyroxine SodiumAurobindo Pharma Limited
- Lorazepamin shortageAurolife Pharma LLC
- Losartan PotassiumAurobindo Pharma Limited
- MeclizineAurobindo Pharma Limited
- Memantine HydrochlorideAurobindo Pharma Limited
- MesalamineAurobindo Pharma Limited
- MethocarbamolAurobindo Pharma Limited
- Midodrine HydrochlorideAurobindo Pharma Limited
- MirtazapineAurobindo Pharma Limited
- Mometasone Furoate MonohydrateAurobindo Pharma Limited
- Montelukast SodiumAurobindo Pharma Limited
- Mycophenolate mofetilAurobindo Pharma Limited
- Mycophenolic AcidAurobindo Pharma Limited
- NaproxenAurobindo Pharma Limited
- NebivololAurobindo Pharma Limited
- NifedipineAurobindo Pharma Limited
- NitrofurantoinRising Pharma Holdings, Inc.
- NitroglycerinAurobindo Pharma Limited
- Pantoprazole SodiumAurobindo Pharma Limited
- pilocarpine hydrochlorideAurobindo Pharma Limited
- PirfenidoneAurobindo Pharma Limited
- Potassium ChlorideAurobindo Pharma Limited
- PrednisoloneAurobindo Pharma Limited
- PrednisoneAurobindo Pharma Limited
- rufinamideAurobindo Pharma Limited
- Sapropterin DihydrochlorideAurobindo Pharma Limited
- Sertraline HydrochlorideAurobindo Pharma Limited
- Sevelamer CarbonateAurobindo Pharma Limited
- Sevelamer HydrochlorideAurobindo Pharma Limited
- SilodosinAurobindo Pharma Limited
- Sulfamethoxazole and TrimethoprimAurobindo Pharma Limited
- Tizanidine HydrochlorideAurobindo Pharma Limited
- TopiramateAurobindo Pharma Limited
- Tramadol HydrochlorideRising Pharma Holdings, Inc.
- Trazodone HydrochlorideAurolife Pharma LLC
- Valacyclovir HydrochlorideAurobindo Pharma Limited
- VareniclineAurobindo Pharma Limited
- VigabatrinAurobindo 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.