Kalintis Healthcare is an API manufacturer based in India. It holds 16 active US drug master files across a filed portfolio of 11 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 17 October 2025 as NAI. Customs aggregates show $3.4M of exports covering 65 molecules to 15 destinations in 2025.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Vadodara, India | 3013455974 |
| Molecule | Regulators | Docs |
|---|---|---|
| Diphenoxylate | US FDA | 4 |
| Torasemide | US FDA | 2 |
| Trimethobenzamide | US FDA | 2 |
| Benzatropine | US FDA | 1 |
| Cevimeline | US FDA | 1 |
| Furosemide | US FDA | 1 |
| Lorazepam | US FDA | 1 |
| Methenamine | US FDA | 1 |
| Methimazole | US FDA | 1 |
| Mexiletine | US FDA | 1 |
| Oxazepam | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| US FDA | None | 1 |
| Year | Revenue | Exports | Destinations |
|---|---|---|---|
| 2026 YTD | Not reported | $242K | 2 |
| 2025 | Not reported | $3.4M | 15 |
| 2024 | Not reported | $3.8M | 8 |
| 2023 | Not reported | $2.3M | 4 |
Export figures are customs aggregates. We do not publish the identity of any buyer.
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