Drug factory · FDA FEI 3004896422
Malladi Drugs and Pharmaceuticals Limited
Plot Nos.49, 50, 55 & 56, IDA, Gajulamandyam, Chittoor, India
No problems found at FDA's last inspection, Jul 3, 2026.
No Action Indicated: inspectors found no objectionable conditions.
5 drug inspections on record since 2014: 1 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Gadoquatrane | Makes the active ingredient | Bayer HealthCare Pharmaceuticals Inc. | 50419-321, 50419-322, 50419-323 +8 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 3, 2026 | No problems found | Drug Quality Assurance | — |
| Jan 31, 2020 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 9, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 4, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 19, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: api manufacture.