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
- Unit I & Unit II, Block C, Phase I, Visakhapatnam Special Economic Zone (VSEZ ), Duvvada, Visakhapatnam, Andhra Pradesh 530049, India (IND)
- Operations here
- analysisapi manufacturelabelmanufacturepack
- FDA identifiers
- FEI 3009056604 · DUNS 650540227
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- NAIDrug Quality Assurance2023-07-28
- VAIDrug Quality Assurance2019-11-01
- NAIDrug Quality Assurance2018-06-15
- NAIDrug Quality Assurance2018-05-18
- NAIDrug Quality Assurance2017-03-31
- VAIDrug Quality Assurance2015-06-30
- NAIDrug Quality Assurance2015-06-25
- VAIDrug Quality Assurance2013-08-05
Drugs this plant is listed as making
29 distinct drugs across 96 products name this site in their FDA label.
- Arsenic TrioxideGland Pharma Limited
- BortezomibHospira, Inc.
- BusulfanHospira, Inc.
- Carboplatinin shortageBPI Labs LLC
- CarmustineHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- CisplatinGland Pharma Limited
- ClofarabineDr.Reddy's Laboratories Inc
- CytarabineGland Pharma Limited
- decitabineGland Pharma Limited
- DocetaxelGland Pharma Limited
- Doxorubicin HydrochlorideGland Pharma Limited
- eribulin mesylateApotex Corp.
- FluorouracilXiromed LLC
- gemcitabine hydrochlorideGland Pharma Limited
- Heparin Sodiumin shortageGland Pharma Limited
- Irinotecan hydrochloideBluePoint Laboratories
- Irinotecan hydrochlorideXiromed LLC
- Melphalan HydrochlorideDr.Reddy's Laboratories Inc
- MitomycinFresenius Kabi USA, LLC
- NelarabineGland Pharma Limited
- OxaliplatinMeitheal Pharmaceuticals Inc.
- paclitaxelGland Pharma Limited
- pemetrexedAvyxa Pharma, LLC
- pemetrexed dipotassiumAvyxa Pharma, LLC
- Pemetrexed disodiumBluePoint Laboratories
- TemsirolimusFresenius Kabi USA, LLC
- Temsirolimus InjectionGland Pharma Limited
- ThiotepaDr.Reddy's Laboratories Inc.,
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.