Granules India 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
- Sy.No. 160/A, 161/E, 162, 174/A, Gagillapur Village, Dundigal-Gandimaisamma Mandal, Medchal-Malkajgiri District, Telangana 500043, India (IND)
- Operations here
- analysislabelmanufacturepack
- FDA identifiers
- FEI 3004097901 · DUNS 918609236
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2020-02-14
- NAIDrug Quality Assurance2018-03-23
- NAIDrug Quality Assurance2016-10-14
- NAIDrug Quality Assurance2015-03-13
- VAIDrug Quality Assurance2012-09-13
- NAIDrug Quality Assurance2009-11-12
Drugs this plant is listed as making
20 distinct drugs across 67 products name this site in their FDA label.
- Bupropion hydrochlorideBluePoint Laboratories
- GabapentinGranules Pharmaceuticals Inc.
- IbuprofenAscend Laboratories, LLC
- LosartanGranules India Ltd
- Losartan Potassium And HydrochlorothiazideGranules Pharmaceuticals Inc.
- Metformin ER 500 mgQuallent Pharmaceuticals Health LLC
- Metformin ER 750 mgQuallent Pharmaceuticals Health LLC
- Metformin HClAscend Laboratories, LLC
- Metformin HydrochlorideEpic Pharma, LLC
- Metformin Hydrochloride TabletQuallent Pharmaceuticals Health LLC
- Methocarbamol TabletsGranules India Ltd
- Metoprolol SuccinateGranules India Ltd
- pantoprazole sodiumGranules Pharmaceuticals Inc.
- Potassium ChlorideGranules Pharmaceuticals Inc
- Potassium Chloride Extended-releaseGranules India Ltd
- Sertraline hydrochlorideGranules Pharmaceuticals Inc.
- Venlafaxine HydrochlorideGranules Pharmaceuticals 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.