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
- Plot no: 42-52, 54, 55, 64-68, Sy. No. 166, 171, 172 & 177, Phase III, TSIIC, Pashamylaram Village, Patancheru Mandal, Sangareddy District, Hyderabad, Telangana 502307, India (IND)
- Operations here
- analysislabelmanufacturepack
- FDA identifiers
- FEI 3009864167 · DUNS 858971074
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2023-06-27
- VAIDrug Quality Assurance2019-11-07
- VAIDrug Quality Assurance2018-02-23
- VAIDrug Quality Assurance2015-09-18
Drugs this plant is listed as making
72 distinct drugs across 177 products name this site in their FDA label.
- AcetazolamideGland Pharma Limited
- AcetylcysteineFresenius Kabi USA, LLC
- Angiotensin IiGland Pharma Limited
- Azithromycin monohydrateSun Pharmaceutical Industries Limited
- Bumetanidein shortageGland Pharma Limited
- carboprost tromethamineGland Pharma Limited
- cetrorelix acetateFresenius Kabi Usa, Llc
- Chlorothiazide sodiumGland Pharma Limited
- Chlorpromazine hydrochloridePiramal Critical Care Inc.
- Cisatracurium besylateGland Pharma Limited
- cyanocobalaminGland Pharma Limited
- DaptomycinPar Health USA, LLC
- Desmopressin Acetatein shortageFresenius Kabi USA, LLC
- Dexamethasone Sodium Phosphatein shortageGland Pharma Limited
- Dexmedetomidinein shortageGland Pharma Limited
- dexmedetomidine hydrochloridein shortageWilshire Pharmaceuticals, Inc.
- Dihydroergotamine MesylateGland Pharma Limited
- Diphenhydramine HydrochlorideGland Pharma Limited
- DoxycyclineGland Pharma Limited
- Enoxaparin SodiumFresenius Kabi USA, LLC
- epinephrineGland Pharma Limited
- EpoprostenolGland Pharma Limited
- ErtapenemNorthStar RxLLC
- Ertapenem SodiumGland Pharma Limited
- erythromycin lactobionateGland Pharma Limited
- fluphenazine decanoateGland Pharma Limited
- Ganirelix AcetateGland Pharma Limited
- GlycopyrrolateXiromed LLC
- Heparin Sodiumin shortageGland Pharma Limited
- isoproterenol hydrochlorideGland Pharma Limited
- Ketamine HydrochlorideGland Pharma Limited
- LevetiracetamHospira, Inc.
- LevoleucovorinGland Pharma Limited
- lincomycin hydrochlorideGland Pharma Limited
- Liraglutidein shortageCipla USA Inc.
- MeropenemGland Pharma Limited
- MethocarbamolJvet Pharmaceuticals Llc
- Midazolam Hydrochloridein shortageGland Pharma Limited
- NeostigmineDr.Reddy's Laboratories Inc
- Neostigmine methylsulfateXiromed LLC
- Norepinephrine bitartrateGland Pharma Limited
- Octreotide AcetateGland Pharma Limited
- OndansetronHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- Pantoprazole sodiumGland Pharma Limited
- Phenylephrine HydrochlorideGland Pharma Limited
- PhytonadioneGland Pharma Limited
- Procainamide HydrochlorideGland Pharma Limited
- Rocuronium Bromidein shortageGland Pharma Limited
- Selenious AcidGland Pharma Limited
- SuccinylcholineDr.Reddy's Laboratories Inc.,
- thiamine hydrochlorideGland Pharma Limited
- Tranexamic acidGland Pharma Limited
- Vancomycin HydrochlorideGland Pharma Limited
- VasopressinGland Pharma Limited
- Verapamil hydrochlorideGland Pharma Limited
- VoriconazoleGland Pharma Limited
- Zinc SulfateGland Pharma Limited
- ziprasidone mesylateGland Pharma Limited
- Zoledronic AcidFresenius Kabi USA, LLC
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.