Saraca Laboratories is an API manufacturer based in India. It holds one active US drug master file and 4 valid CEPs across a filed portfolio of 4 molecules. Its GMP standing is certified by EMA. Its most recent recorded inspection, by US FDA, closed on 14 February 2020 as VAI. Customs aggregates show $2.5M of exports covering 64 molecules to 16 destinations in 2025.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Gaddapotharam Village, India | Not on file |
| Srikakulam, India | Not on file |
| Hyderabad, India | Not on file |
| Sangareddy, India | 3004641543 |
| Molecule | Regulators | Docs |
|---|---|---|
| Gabapentin | EDQM, US FDA | 2 |
| Ranitidine | EDQM, SFDA (Saudi Arabia) | 2 |
| Pantoprazole | EDQM | 1 |
| Pregabalin | EDQM | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| EMA | None | 1 |
| Year | Revenue | Exports | Destinations |
|---|---|---|---|
| 2026 YTD | Not reported | $620K | 8 |
| 2025 | Not reported | $2.5M | 16 |
| 2024 | Not reported | $3.7M | 17 |
| 2023 | Not reported | $2.2M | 14 |
Export figures are customs aggregates. We do not publish the identity of any buyer.
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