Drug factory · FDA FEI 3009915929
Glenmark Pharmaceuticals Limited
Plot No. B-25, MIDC, Shendra, Chhatrapati Sambhajinagar (previously known as Aurangabad), India
No problems found at FDA's last inspection, Sep 20, 2024.
No Action Indicated: inspectors found no objectionable conditions.
5 drug inspections on record since 2016: 3 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Abiraterone | Makes it and tests it | Glenmark Pharmaceuticals Inc., USA, Northstar Rx LLC. | 68462-135, 68462-882, 72603-110 +1 |
| Clindamycin | Makes it and tests it | Glenmark Pharmaceuticals Inc., USA | 68462-605 |
| Clobetasol | Makes it and tests it | Glenmark Pharmaceuticals Inc., USA | 68462-608, 68462-625 |
| Fluticasone | Makes it and tests it | Glenmark Pharmaceuticals Inc., USA | 68462-918, 68462-937 |
| Mometasone and Olopatadine | Makes it and tests it | Glenmark Pharmaceuticals Inc., USA, Hikma Specialty USA Inc. | 68462-659, 59467-700 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 20, 2024 | No problems found | Drug Quality Assurance | — |
| Dec 15, 2023 | No problems found | Bioresearch Monitoring | — |
| Feb 21, 2020 | No problems found | Drug Quality Assurance | — |
| Aug 17, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 17, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; label; manufacture; pack.