Swati Spentose is an API manufacturer based in India. It holds 23 active US drug master files and 7 valid CEPs across a filed portfolio of 14 molecules. Its GMP standing is certified by CDSCO (India), US FDA and EMA. Its most recent recorded inspection, by US FDA, closed on 31 May 2024 as VAI. Customs aggregates show $20.3M of exports covering 630 molecules to 68 destinations in 2025.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Mumbai, India | Not on file |
| Vapi, India | Not on file |
| vapi valsad 396 195, India | Not on file |
| vapi 396 195 valsad, India | Not on file |
| Vapi, India | Not on file |
| Vapi, India | 3009765202 |
4 further sites are on record.
| Molecule | Regulators | Docs |
|---|---|---|
| Lidocaine | EDQM, SFDA (Saudi Arabia), US FDA | 9 |
| Prilocaine | EDQM, SFDA (Saudi Arabia), US FDA | 7 |
| Granisetron | SFDA (Saudi Arabia), US FDA | 3 |
| Melatonin | EDQM, US FDA | 3 |
| Meloxicam | SFDA (Saudi Arabia), US FDA | 3 |
| Tamsulosin | EDQM, US FDA | 3 |
| Glycopyrronium | US FDA | 2 |
| Pentosan Polysulfate Sodium | US FDA | 2 |
| Silodosin | US FDA | 2 |
| Dutasteride | EDQM | 1 |
| Fluocinolone Acetonide | SFDA (Saudi Arabia) | 1 |
| Lidocaine Hci | SFDA (Saudi Arabia) | 1 |
| Mirabegron | US FDA | 1 |
| Triamcinolone Acetonide | EDQM | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| CDSCO (India) | 5 | 9 |
| US FDA | None | 1 |
| EMA | None | 1 |
| Year | Revenue | Exports | Destinations |
|---|---|---|---|
| 2026 YTD | Not reported | $2.9M | 40 |
| 2025 | Not reported | $20.3M | 68 |
| 2024 | Not reported | $13.8M | 68 |
| 2023 | Not reported | $12.1M | 59 |
Export figures are customs aggregates. We do not publish the identity of any buyer.
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