Drug factory · FDA FEI 3008405956
Apothecon Pharmaceuticals Private Limited
Plot No.1134 to 1137, 1138 A&B, 1143 A&B, 1144 A&B, Padra-Jambusar Highway, At & Post:-Dabhasa, Taluka Padra, , Vadodara, India
Problems found, fixed voluntarily at FDA's last inspection, Jan 27, 2023.
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 2015: 1 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Carglumic Acid | Makes it | Navinta LLC | 68475-006 |
| Diazepam | Makes it, tests it and packages it | Navinta LLC | 68475-802, 68475-803, 68475-804 |
| Famotidine | Makes it, tests it and packages it | Zydus Pharmaceuticals (USA) Inc. | 68382-444 |
| Nicardipine | Makes the active ingredient and tests it | Cipla USA., Inc. | 69097-007, 69097-008 |
| Penicillamine | Makes it | Navinta LLC | 68475-201 |
| Phenylbutyric Acid | Makes it, makes the active ingredient, tests it and packages it | Navinta LLC, Zydus Pharmaceuticals (USA) Inc. | 68475-807, 70710-2193 |
| Sevelamer | Makes it, tests it and packages it | Navinta LLC | 68475-010 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 27, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 24, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 14, 2015 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; manufacture; pack.