Drug factory · FDA FEI 3007197995
Shilpa Pharma Lifesciences Limited
Plot No.33, 33A & 40 to 47, Raichur Industrial Growth Centre, Chicksugur, Raichur, India
No problems found at FDA's last inspection, Mar 14, 2025.
No Action Indicated: inspectors found no objectionable conditions.
6 drug inspections on record since 2013: 2 with no problems, 3 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Gemcitabine | Tests it | Janssen Biotech, Inc. | 57894-225 |
| Pemetrexed | Makes the active ingredient | Biocon Pharma Inc. | 70377-022 |
| Prucalopride | Makes the active ingredient | Hikma Pharmaceuticals USA Inc. | 0054-0749, 0054-0750 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 14, 2025 | No problems found | Drug Quality Assurance | — |
| Feb 7, 2020 | No problems found | Drug Quality Assurance | — |
| Jul 26, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 16, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 9, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 3, 2013 | Serious problems, FDA action | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture.