Drug factory · FDA FEI 3008256596
Teva API India Private Ltd.
Plot No. Q1 to Q4 Industrial Area Ghirongi, Malanpur, India
Problems found, fixed voluntarily at FDA's last inspection, Nov 28, 2019.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
4 drug inspections on record since 2015: 1 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Doxepin | Makes the active ingredient and tests it | Currax Pharmaceuticals LLC dba Cypress, Hawthorn, Macoven | 44183-103, 44183-106 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 28, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 16, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 15, 2018 | No problems found | Drug Quality Assurance | — |
| Apr 24, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture.