Caplin Steriles is a finished-dose manufacturer based in India. It appears in 52 regulatory filings across 3 regulators, without an active US DMF or CEP on file. Its filings concentrate with US FDA, COFEPRIS (MX) and MINSA (CR). Its GMP standing is certified by ANVISA (Brazil), CDSCO (India) and US FDA, among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 9 August 2024 as NAI. Customs aggregates show $5.0M of exports covering 102 molecules to 5 destinations in 2025.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Gummidipoondi, United Arab Emirates | Not on file |
| Gummidipoondi, India | 3005035920 |
| THIRUVALLUR, India | Not on file |
| Regulator | Filings | GMP certificates |
|---|---|---|
| US FDA | 40 | 1 |
| COFEPRIS (MX) | 7 | None |
| MINSA (CR) | 5 | None |
| ANVISA (Brazil) | None | 2 |
| CDSCO (India) | None | 2 |
| EMA | None | 1 |
| Year | Revenue | Exports | Destinations |
|---|---|---|---|
| 2026 YTD | Not reported | $2.7M | 7 |
| 2025 | Not reported | $5.0M | 5 |
| 2024 | Not reported | $20 | 1 |
| 2023 | Not reported | $320K | 1 |
Export figures are customs aggregates. We do not publish the identity of any buyer.
Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.
Choose your molecules and target markets. Caplin Steriles comes back tiered against every other supplier able to file there.
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