Drug factory · FDA FEI 3013637926
Biocon Pharma Limited
Special Economic Zone, Block F1, Plot No.5, Phase IV, Bommasandra - Jigani Link Road, Bommasandra Post, Bengaluru, India
No problems found at FDA's last inspection, Jun 2, 2023.
No Action Indicated: inspectors found no objectionable conditions.
1 drug inspection on record since 2023: 1 with no problems, 0 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|
| Atorvastatin | Makes it, tests it and packages it |
Biocon Pharma Inc. |
70377-077, 70377-078, 70377-079 +1 |
| Dapagliflozin | Makes it and packages it |
Biocon Pharma Inc. |
70377-023, 70377-024 |
| Dasatinib | Makes it |
Biocon Pharma Inc., BluePoint Laboratories., Quallent Pharmaceuticals Health LLC |
70377-083, 70377-084, 70377-085 +15 |
| Everolimus | Makes it, tests it and packages it |
Biocon Pharma Inc., Northstar Rx LLC., Upsher-Smith Laboratories, Inc. |
70377-010, 70377-011, 70377-012 +16 |
| Fingolimod | Makes it |
Biocon Pharma Inc., Quallent Pharmaceuticals Health LLC |
70377-019, 82009-143 |
| Mycophenolic Acid | Makes it, tests it and packages it |
Biocon Pharma Inc. |
70377-039, 70377-040 |
| Posaconazole | Makes it, tests it and packages it |
Biocon Pharma Inc. |
70377-038 |
| Rosuvastatin | Makes it |
Biocon Pharma Inc. |
70377-006, 70377-007, 70377-008 +1 |
| Sacubitrilat and Valsartan | Makes it and packages it |
Biocon Pharma Inc. |
70377-031, 70377-032, 70377-033 |
| Tacrolimus | Makes it |
Biocon Pharma Inc. |
70377-014, 70377-015, 70377-016 |
| Teriflunomide | Makes it |
Biocon Pharma Inc. |
70377-017, 70377-018 |
| Tofacitinib | Makes it |
Biocon Pharma Inc. |
70377-057 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|
| Jun 2, 2023 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; manufacture; pack; repack.