Drug factory · FDA FEI 3010164491
Biocon Limited
Special Economic Zone, Plot No. 2, 3, 4 & 5, Phase IV, Bommasandra-Jigani Link Road, Bommasandra Post, Bengaluru, India
Problems found, fixed voluntarily at FDA's last inspection, Sep 27, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
3 drug inspections on record since 2016: 1 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Everolimus | Makes the active ingredient | Biocon Pharma Inc., Northstar Rx LLC. | 70377-010, 70377-011, 70377-012 +5 |
| Posaconazole | Makes the active ingredient | Biocon Pharma Inc. | 70377-038 |
| Simvastatin | Makes the active ingredient | PuraCap Laboratories LLC dba Blu Pharmaceuticals | 24658-500, 24658-501, 24658-502 +2 |
| Tacrolimus | Makes the active ingredient | Biocon Pharma Inc. | 70377-014, 70377-015, 70377-016 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 27, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 24, 2020 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 8, 2016 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture.