Drug factory · FDA FEI 3006625990
Porton Pharma Solutions Ltd
1 Fine Chemical Zone, Chongqing Chemical Industry Park, Changshou, Chongqing, China
No problems found at FDA's last inspection, Mar 29, 2024.
No Action Indicated: inspectors found no objectionable conditions.
3 drug inspections on record since 2015: 1 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Bedaquiline | Makes the active ingredient | Janssen Products LP | 59676-701, 59676-702 |
| Cobicistat and Darunavir | Makes the active ingredient | Janssen Products LP | 59676-575, 59676-577, 59676-578 |
| Darunavir | Makes the active ingredient | Janssen Products LP | 59676-562, 59676-563, 59676-564 +1 |
| Darunavir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide | Makes the active ingredient | Janssen Products LP | 59676-800 |
| Tipranavir | Makes the active ingredient | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0003 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 29, 2024 | No problems found | Drug Quality Assurance | — |
| Nov 23, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 11, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: api manufacture.