Manufacturing facility
Aurobindo Pharma 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-VII, Sy No. 411/P, 425/P, 434/P, 435/P & 458/P, Plot S1 Part SEZ, TSIIC, Green Industrial Park, Polepally, Jedcherla Mandal, Mahabubnagar, Telangana 509302, India (IND)
- Operations here
- analysismanufacture
- FDA identifiers
- FEI 3007373532 · DUNS 650381903
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2022-05-10
- OAIDrug Quality Assurance2019-09-27
- NAIDrug Quality Assurance2017-06-24
- NAIDrug Quality Assurance2015-03-13
- NAIDrug Quality Assurance2012-06-19
- VAIDrug Quality Assurance2010-07-30
- NAIDrug Quality Assurance2009-10-13
Drugs this plant is listed as making
140 distinct drugs across 450 products name this site in their FDA label.
- AbacavirAurobindo Pharma Limited
- AlprazolamAurobindo Pharma Limited
- Amiodarone HydrochlorideAurobindo Pharma Limited
- Amlodipine and Benazepril HydrochlorideRising Pharma Holdings, Inc.
- Amlodipine and Olmesartan MedoxomilAurobindo Pharma Limited
- Amlodipine and valsartanAurobindo Pharma Limited
- Amlodipine, Valsartan and HydrochlorothiazideAurobindo Pharma Limited
- ArmodafinilAurobindo Pharma Limited
- AtazanavirAurobindo Pharma Limited
- Atorvastatin CalciumAurobindo Pharma Limited
- AzithromycinAurobindo Pharma Limited
- Bisoprolol Fumarate and HydrochlorothiazideAurobindo Pharma Limited
- CelecoxibAurobindo Pharma Limited
- CinacalcetAurobindo Pharma Limited
- ClozapineAurobindo Pharma Limited
- Dabigatran EtexilateAurobindo Pharma Limited
- DalfampridineAurobindo Pharma Limited
- DarifenacinAurobindo Pharma Limited
- desmopressin acetatein shortageAurobindo Pharma Limited
- Desogestrel and Ethinyl EstradiolAurobindo Pharma Limited
- Desogestrel and Ethinyl Estradiol and Ethinyl EstradiolAurobindo Pharma Limited
- Divalproex sodiumAurobindo Pharma Limited
- Drospirenone and Ethinyl EstradiolAurobindo Pharma Limited
- DutasterideAurobindo Pharma Limited
- Dutasteride and Tamsulosin HydrochlorideAurobindo Pharma Limited
- EfavirenzAurobindo Pharma Limited
- Efavirenz, Emtricitabine and Tenofovir Disoproxil FumarateAurobindo Pharma Limited
- Emtricitabine and Tenofovir Disoproxil FumarateAurobindo Pharma Limited
- EntacaponeAurobindo Pharma Limited
- EntecavirAurobindo Pharma Limited
- Esomeprazole MagnesiumAurobindo Pharma Limited
- EstradiolAurobindo Pharma Limited
- Estradiol And Norethindrone AcetateAurobindo Pharma Limited
- EzetimibeAurobindo Pharma Limited
- FamotidineAurobindo Pharma Limited
- FelodipineRising Pharma Holdings, Inc.
- FenofibrateAurobindo Pharma Limited
- Fenofibric AcidAurobindo Pharma Limited
- Fesoterodine FumarateAurobindo Pharma Limited
- FingolimodAurobindo Pharma Limited
- Flecainide AcetateRising Pharma Holdings, Inc.
- Fluoxetine HydrochlorideAurobindo Pharma Limited
- GabapentinAurobindo Pharma Limited
- GalantamineAurobindo Pharma Limited
- GemfibrozilRising Pharma Holdings, Inc.
- GlimepirideAurobindo Pharma Limited
- GlipizideAurobindo Pharma Limited
- Ibandronate SodiumAurobindo Pharma Limited
- Ibuprofen and famotidineAurobindo Pharma Limited
- IrbesartanAurobindo Pharma Limited
- Irbesartan and HydrochlorothiazideAurobindo Pharma Limited
- LamivudineAurobindo Pharma Limited
- Lamivudine and ZidovudineAurobindo Pharma Limited
- LansoprazoleAurobindo Pharma Limited
- LevofloxacinAurobindo Pharma Limited
- Levonorgestrel and Ethinyl EstradiolAurobindo Pharma Limited
- Levonorgestrel and Ethinyl Estradiol and Ethinyl EstradiolAurobindo Pharma Limited
- Loperamide HydrochlorideNorthStar Rx LLC
- Losartan Potassium and HydrochlorothiazideAurobindo Pharma Limited
- Meclizine HydrochlorideRising Pharma Holdings, Inc.
- Memantine HydrochlorideAurobindo Pharma Limited
- Methenamine HippurateNorthStar Rx LLC
- Metronidazolein shortageAurobindo Pharma Limited
- Minocycline HydrochlorideAurobindo Pharma Limited
- ModafinilAurobindo Pharma Limited
- Montelukast SodiumAurobindo Pharma Limited
- moxifloxacin hydrochlorideAurobindo Pharma Limited
- NaproxenAurobindo Pharma Limited
- Naproxen SodiumAurobindo Pharma Limited
- NevirapineAurobindo Pharma Limited
- Nitrofurantoin (Monohydrate/Macrocrystals)Aurobindo Pharma Limited
- NorethindroneAurobindo Pharma Limited
- Norethindrone Acetate and Ethinyl EstradiolAurobindo Pharma Limited
- Norethindrone Acetate and Ethinyl Estradiol and Ferrous FumarateAurobindo Pharma Limited
- Norethindrone and Ethinyl EstradiolAurobindo Pharma Limited
- norethindrone and ethinyl estradiol and ferrous fumarateAurobindo Pharma Limited
- norethindrone and ethinyl estradiol tabletAurobindo Pharma Limited
- Norgestimate and Ethinyl EstradiolAurobindo Pharma Limited
- OlanzapineAurobindo Pharma Limited
- Olmesartan MedoxomilAurobindo Pharma Limited
- Olmesartan Medoxomil and HydrochlorothiazideAurobindo Pharma Limited
- OmeprazoleRising Pharma Holdings, Inc.
- Pantoprazole SodiumNCS HealthCare of KY, LLC dba Vangard Labs
- ParicalcitolAurobindo Pharma Limited
- Phenytoin SodiumAurobindo Pharma Limited
- Pioglitazone Hydrochloride and Metformin HydrochlorideRising Pharma Holdings, Inc.
- PitavastatinAurobindo Pharma Limited
- PosaconazoleAurobindo Pharma Limited
- Pramipexole DihydrochlorideRising Pharma Holdings, Inc.
- PrasugrelAurobindo Pharma Limited
- Prazosin HydrochlorideAurobindo Pharma Limited
- PregabalinAurobindo Pharma Limited
- prochlorperazine maleateAurobindo Pharma Limited
- Propafenone HydrochlorideAurobindo Pharma Limited
- QuetiapineAurobindo Pharma Limited
- Quinapril Hydrochloridein shortageAurobindo Pharma Limited
- Rabeprazole SodiumAurobindo Pharma Limited
- Raloxifene HydrochlorideAurobindo Pharma Limited
- RitonavirAurobindo Pharma Limited
- RivaroxabanAurobindo Pharma Limited
- Rivastigmine TartrateAurobindo Pharma Limited
- Rizatriptan BenzoateAurobindo Pharma Limited
- RoflumilastAurobindo Pharma Limited
- SaxagliptinAurobindo Pharma Limited
- Sertraline HydrochlorideAurobindo Pharma Limited
- Sevelamer CarbonateAurobindo Pharma Limited
- SildenafilAurobindo Pharma Limited
- SimvastatinAurobindo Pharma Limited
- Solifenacin SuccinateAurobindo Pharma Limited
- Sulfamethoxazole and TrimethoprimAurobindo Pharma Limited
- Sumatriptan and Naproxen SodiumAurobindo Pharma Limited
- TadalafilAurobindo Pharma Limited
- Tamsulosin HydrochlorideAurobindo Pharma Limited
- TelmisartanAurobindo Pharma Limited
- Telmisartan and HydrochlorothiazideAurobindo Pharma Limited
- Tenofovir Disoproxil FumarateAurobindo Pharma Limited
- TeriflunomideAurobindo Pharma Limited
- Tramadol HydrochlorideRising Pharma Holdings, Inc.
- Tramadol Hydrochloride and AcetaminophenAurobindo Pharma Limited
- Valacyclovir HydrochlorideRising Pharma Holdings, Inc.
- Valganciclovir HydrochlorideAurobindo Pharma Limited
- ValsartanAurobindo Pharma Limited
- Valsartan and HydrochlorothiazideAurobindo Pharma Limited
- VoriconazoleAurobindo Pharma Limited
- ZidovudineAurobindo Pharma Limited
- Ziprasidone HydrochlorideAurobindo Pharma Limited
- ZolmitriptanRising Pharma Holdings, Inc.
- Zolpidem TartrateAurobindo 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.