Drug factory · FDA FEI 3010142300
Gland Pharma Limited
Plot no: 49 & 50, J. N. Pharmacity, Parawada (M), Anakapalli District, India
No problems found at FDA's last inspection, May 24, 2024.
No Action Indicated: inspectors found no objectionable conditions.
4 drug inspections on record since 2015: 3 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Tigecycline | Makes the active ingredient | Apotex Corp. | 60505-6098 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 24, 2024 | No problems found | Drug Quality Assurance | — |
| Jan 27, 2023 | No problems found | Drug Quality Assurance | — |
| Apr 20, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 29, 2015 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; pack.