Maithri Laboratories is an API manufacturer based in India. It holds 46 active US drug master files and 7 valid CEPs across a filed portfolio of 23 molecules. Its GMP standing is certified by EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 2 May 2025 as VAI. Customs aggregates show $1.7M of exports covering 60 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 |
| Sangareddy, India | Not on file |
| Sangareddy District, India | 3007800082 |
| Molecule | Regulators | Docs |
|---|---|---|
| Brivaracetam | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Eliglustat | US FDA | 4 |
| Rabeprazole | US FDA | 4 |
| Buspirone | EDQM, US FDA | 3 |
| Flucytosine | EDQM, US FDA | 3 |
| Pyridostigmine | EDQM, US FDA | 3 |
| Tolterodine | EDQM, US FDA | 3 |
| Apixaban | US FDA | 2 |
| Betahistine | US FDA | 2 |
| Chlorpromazine | US FDA | 2 |
| Cysteamine | US FDA | 2 |
| Daridorexant | US FDA | 2 |
| Elafibranor | US FDA | 2 |
| Escitalopram | US FDA | 2 |
| Fesoterodine | US FDA | 2 |
| Gepirone | US FDA | 2 |
| Ivabradine | US FDA | 2 |
| Lumateperone | US FDA | 2 |
| Suvorexant | US FDA | 2 |
| Valganciclovir | US FDA | 2 |
| Viloxazine | US FDA | 2 |
| Chlorpromazine Hydrochloride | EDQM | 1 |
| Valganciclovir Hydrochloride | EDQM | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| CDSCO (India) | 4 | None |
| EMA | None | 1 |
| US FDA | None | 1 |
| Year | Revenue | Exports | Destinations |
|---|---|---|---|
| 2026 YTD | Not reported | $871K | 9 |
| 2025 | Not reported | $1.7M | 16 |
| 2024 | Not reported | $2.4M | 12 |
| 2023 | Not reported | $2.8M | 7 |
Export figures are customs aggregates. We do not publish the identity of any buyer.
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