Drug factory · FDA FEI 3004956855
Biocon Limited
Plot No. 213-215 and 216/B, Phase II IDA, Pashamylaram, Sangareddy, India
No problems found at FDA's last inspection, May 19, 2023.
No Action Indicated: inspectors found no objectionable conditions.
3 drug inspections on record since 2014: 3 with no problems, 0 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Dapagliflozin | Makes the active ingredient | Biocon Pharma Inc. | 70377-023, 70377-024 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 19, 2023 | No problems found | Drug Quality Assurance | — |
| Dec 14, 2018 | No problems found | Drug Quality Assurance | — |
| Jun 6, 2014 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture.