Manufacturing facility
Gland 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
- Survey No. 143 - 148, 150 & 151, Near Gandimaisamma Cross Roads, D. P. Pally, Dundigal Post, Dundigal - Gandimaisamma Mandal, Medchal - Malkajgiri District, Hyderabad, Telangana 500043, India (IND)
- Operations here
- analysisapi manufacturelabelmanufacturepack
- FDA identifiers
- FEI 3002647489 · DUNS 918601238
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2024-07-25
- VAIDrug Quality Assurance2023-07-14
- VAIDrug Quality Assurance2019-05-16
- VAIDrug Quality Assurance2017-02-03
- VAIDrug Quality Assurance2015-03-17
- VAIDrug Quality Assurance2012-09-07
- NAIDrug Quality Assurance2011-01-07
Drugs this plant is listed as making
132 distinct drugs across 283 products name this site in their FDA label.
- AcetaminophenGland Pharma Limited
- AcetylcysteineFresenius Kabi USA, LLC
- AdenosineGland Pharma Limited
- AllopurinolGland Pharma Limited
- Amiodarone hydrochlorideGland Pharma Limited
- ArgatrobanGland Pharma Limited
- Azelastine HydrochlorideGland Pharma Limited
- Azelastine Hydrochloride Ophthalmic Solution 0.05%Alembic Pharmaceuticals Inc.
- Azithromycin monohydrateSun Pharmaceutical Industries Limited
- BaclofenMAlA Pharmaceuticals, Inc.
- BimatoprostGland Pharma Limited
- BivalirudinDr. Reddy's Laboratories Limited
- bortezomibMAIA Pharmaceuticals, Inc.
- Brimonidine TartrateGland Pharma Limited
- BromfenacGland Pharma Limited
- Bromfenac Ophthalmic Solution 0.09%Alembic Pharmaceuticals Inc.
- CalcitriolGland Pharma Limited
- CangrelorGland Pharma Limited
- Caspofungin AcetateGland Pharma Limited
- DaptomycinDr.Reddy's Laboratories Inc.,
- Deferoxamine mesylateGland Pharma Limited
- Dexmedetomidinein shortageGland Pharma Limited
- dexmedetomidine hydrochloridein shortageWilshire Pharmaceuticals, Inc.
- DexrazoxaneEugia US LLC
- Dexrazoxane for InjectionGland Pharma Limited
- DiazepamCivica, Inc.
- Dorzolamide HydrochlorideAlembic Pharmaceuticals Inc.
- Dorzolamide Hydrochloride and Timolol MaleateGland Pharma Limited
- Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic SolutionAlembic Pharmaceuticals Inc.
- DoxercalciferolGland Pharma Limited
- edaravoneGland Pharma Limited
- Enoxaparin SodiumFresenius Kabi USA, LLC
- Ephedrine SulfateGland Pharma Limited
- Esmolol HydrochlorideGland Pharma Limited
- Esomeprazole SodiumGland Pharma Limited
- Etomidate Injectionin shortageGland Pharma Limited
- FomepizoleGland Pharma Limited
- Fondaparinux SodiumDr. Reddy's Laboratories Limited
- Foscarnet SodiumGland Pharma Limited
- Fosphenytoin sodiumGlenmark Pharmaceuticals Inc., Usa
- Furosemidein shortageGland Pharma Limited
- Heparin Sodiumin shortageGland Pharma Limited
- IcatibantCipla USA Inc.
- isoproterenol hydrochlorideCipla USA Inc.
- Ketamine HydrochlorideBaxter Healthcare Corporation
- ketorolac tromethaminein shortageGland Pharma Limited
- Labetalol HydrochlorideGland Pharma Limited
- latanoprostGland Pharma Limited
- Latanoprostene Bunod Ophthalmic Solution, 0.024%Gland Pharma Limited
- Leucovorin CalciumGland Pharma Limited
- LevetiracetamGland Pharma Limited
- Levetiracetam InjectionDr.Reddy's Laboratories Inc
- LevofloxacinGland Pharma Limited
- LevoleucovorinDr.Reddy's Laboratories Inc
- Levothyroxine Sodium AnhydrousMAIA Pharmaceuticals, Inc.
- Liraglutidein shortageOrbicular Pharmaceutical Technologies Private Limited
- Magnesium Sulfate HeptahydrateGland Pharma Limited
- Mesna InjectionGland Pharma Limited
- Metoprolol TartrateGland Pharma Limited
- Metronidazolein shortageGland Pharma Limited
- Micafungin SodiumFresenius Kabi USA, LLC
- Midazolam Hydrochloridein shortageSagent Pharmaceuticals
- Midazolam In Sodium ChlorideGland Pharma Limited
- Milrinone LactateHospira, Inc.
- Milrinone Lactate in DextroseHospira, Inc.
- Moxifloxacin OphthalmicGland Pharma Limited
- Moxifloxacin ophthalmic solutionAlembic Pharmaceuticals Inc.
- naloxone hydrochlorideBaxter Healthcare Corporation
- nicardipine hydrochlorideCipla USA Inc.
- olopatadine hydrochlorideAlembic Pharmaceuticals Inc.
- OndansetronHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- PalonosetronDr.Reddy's Laboratories Limited
- Pantoprazole sodiumGland Pharma Limited
- Phenylephrine HydrochlorideDr.Reddy's Laboratories Inc.,
- PhytonadioneOrbicular Pharmaceutical Technologies Private Limited
- PlerixaforGland Pharma Limited
- Polymyxin B SulfateFresenius Kabi USA, LLC
- posaconazoleGlenmark Pharmaceuticals Inc., Usa
- Prochlorperazine EdisylateGland Pharma Limited
- RegadenosonGland Pharma Limited
- Rocuronium Bromidein shortageGland Pharma Limited
- Ropivacaine Hydrochloridein shortageBaxter Healthcare Corporation
- SincalideMAIA Pharmaceuticals, Inc.
- Sodium Phenylacetate and Sodium BenzoateMaia Pharmaceuticals
- Succinylcholine ChlorideBaxter Healthcare Corporation
- Sumatriptan SuccinateSun Pharmaceutical Industries, Inc.
- TigecyclineAmneal Pharmaceuticals LLC
- timolol maleate ophthalmic gel formingGland Pharma Limited
- timolol maleate ophthalmic gel forming solutionGland Pharma Limited
- Timolol Maleate Ophthalmic Gel Forming Solution, 0.25%Alembic Pharmaceuticals Inc.
- Timolol Maleate Ophthalmic Gel Forming Solution, 0.5%Alembic Pharmaceuticals Inc.
- TirofibanGland Pharma Limited
- TobramycinXiromed LLC
- Tobramycin Ophthalmic SolutionAlembic Pharmaceuticals Inc.
- Tranexamic AcidHeritage Pharmaceuticals Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.
- Travoprost Ophthalmic SolutionGlenmark Pharmaceuticals Inc
- Travoprost Ophthalmic Solution USP, 0.004%Alembic Pharmaceuticals Inc.
- Vancomycin HydrochlorideFresenius Kabi USA, LLC
- Vecuronium BromideMullan Pharmaceutical Inc.
- VoriconazoleFresenius Kabi USA, LLC
- Zinc SulfatePiramal Critical Care Inc.
- zoledronic acidGland 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.