Smilax Laboratories is an API manufacturer based in India. It holds 8 valid CEPs across a filed portfolio of 8 molecules. Its GMP standing is certified by EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 15 September 2023 as VAI. Customs aggregates show $11.5M of exports covering 234 molecules to 33 destinations in 2025.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Hyderabad, India | 3006251127 |
| Visakhapatnam, India | 3008772334 |
| Molecule | Regulators | Docs |
|---|---|---|
| Omeprazole | EDQM, SFDA (Saudi Arabia) | 2 |
| Candesartan Cilexetil | EDQM | 1 |
| Escitalopram | EDQM | 1 |
| Esomeprazole | EDQM | 1 |
| Guaifenesin | EDQM | 1 |
| Pantoprazole | EDQM | 1 |
| Sildenafil | EDQM | 1 |
| Valsartan | EDQM | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| EMA | None | 1 |
| US FDA | None | 1 |
| Year | Revenue | Exports | Destinations |
|---|---|---|---|
| 2026 YTD | Not reported | $1.6M | 22 |
| 2025 | Not reported | $11.5M | 33 |
| 2024 | Not reported | $10.9M | 34 |
| 2023 | Not reported | $22.4M | 34 |
Export figures are customs aggregates. We do not publish the identity of any buyer.
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