Drug factory · FDA FEI 3001319869
Granules India Limited
Plot No.15 A/1, Phase-III, IDA, Jeedimetla, Quthbullapur Mandal, Medchal-Malkajgiri District, India
No problems found at FDA's last inspection, Jun 23, 2023.
No Action Indicated: inspectors found no objectionable conditions.
5 drug inspections on record since 2009: 1 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Canagliflozin and Metformin | Makes the active ingredient and tests it | Janssen Pharmaceuticals, Inc. | 50458-540, 50458-541, 50458-542 +1 |
| Metformin | Makes it | Metcure Pharmaceuticals, Inc. | 71709-110, 71709-111, 71709-112 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 23, 2023 | No problems found | Drug Quality Assurance | — |
| Mar 23, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 18, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 8, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 6, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; label; pack.