Drug factory · FDA FEI 3003971663
SMS Pharmaceuticals Limited
Unit-II, Plot No.24&24B and 36&37, S.V.Co-Operative Industrial Estate, Bachupally, Medchal-Malkajgiri District, Hyderabad, India
Problems found, fixed voluntarily at FDA's last inspection, Mar 21, 2025.
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 2011: 2 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Macitentan and Tadalafil | Makes the active ingredient, tests it, packages it and labels it | Actelion Pharmaceuticals US, Inc. | 66215-812, 66215-814 |
| Meloxicam and Rizatriptan | Makes the active ingredient | Axsome Therapeutics, Inc. | 81968-020 |
| Sumatriptan | Makes the active ingredient, tests it, packages it and labels it | Promius Pharma, LLC., Upsher-Smith Laboratories, LLC | 67857-812, 0245-0812 |
| Tadalafil | Makes the active ingredient, tests it and packages it | Cipla USA., Inc. | 69097-526 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 21, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 17, 2017 | No problems found | Drug Quality Assurance | — |
| Apr 18, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 4, 2011 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; label; pack.