Drug factory · FDA FEI 3013151303
Unique Pharmaceutical Laboratories
Plot No. 4, Phase IV, G.I.D.C Industrial Estate, Bharuch, India
No problems found at FDA's last inspection, Mar 7, 2025.
No Action Indicated: inspectors found no objectionable conditions.
2 drug inspections on record since 2018: 1 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Atenolol | Makes it and tests it | Rising Pharma Holdings, Inc. | 64980-437, 64980-438, 64980-439 |
| Ciprofloxacin | Makes it and tests it | Rising Pharma Holdings, Inc. | 16571-411, 16571-412 |
| Diclofenac | Makes it | BluePoint Laboratories., Rising Pharma Holdings, Inc. | 68001-279, 68001-280, 68001-281 +3 |
| Enalaprilat | Makes it and tests it | Rising Pharma Holdings, Inc. | 64980-685, 64980-686, 64980-687 +1 |
| Glipizide | Makes it | Rising Pharma Holdings, Inc. | 64980-279, 64980-280, 64980-281 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 7, 2025 | No problems found | Drug Quality Assurance | — |
| Dec 8, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; manufacture.