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
- Plot No.15 A/1, Phase-III, IDA, Jeedimetla, Quthbullapur Mandal, Medchal-Malkajgiri District, Telangana 500055, India (IND)
- Operations here
- analysisapi manufacturelabelpack
- FDA identifiers
- FEI 3001319869 · DUNS 918457644
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- NAIDrug Quality Assurance2023-06-23
- VAIDrug Quality Assurance2018-03-23
- VAIDrug Quality Assurance2015-12-18
- VAIDrug Quality Assurance2013-05-08
- VAIDrug Quality Assurance2009-03-06
Drugs this plant is listed as making
2 distinct drugs across 7 products name this site in their FDA label.
- canagliflozin and metformin hydrochlorideJanssen Pharmaceuticals, Inc.
- Metformin HydrochlorideMetcure 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.