Drug factory · FDA FEI 3000280991
Gland Chemicals Private Limited
Plot No. 30 A & B, 2nd Phase, KIADB Industrial Area, Kolar District, Malur, India
No problems found at FDA's last inspection, Dec 14, 2023.
No Action Indicated: inspectors found no objectionable conditions.
3 drug inspections on record since 2013: 3 with no problems, 0 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Rocuronium | Makes the active ingredient, tests it and packages it | Hospira, Inc. | 0409-1403, 0409-3189, 0409-5160 +1 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Dec 14, 2023 | No problems found | Drug Quality Assurance | — |
| May 12, 2016 | No problems found | Drug Quality Assurance | — |
| Aug 1, 2013 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; pack.