Maithri Drugs is an API manufacturer based in India. It holds 72 active US drug master files and 17 valid CEPs. Its GMP standing is certified by US FDA and EMA. Its most recent recorded inspection, by US FDA, closed on 20 June 2025 as VAI. Customs aggregates show $7.3M of exports covering 228 molecules to 37 destinations in 2025.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Bonthapally Village, India | Not on file |
| Sangareddy District, India | 3012234942 |
| Bonthapally, India | Not on file |
| Molecule | Regulators | Docs |
|---|---|---|
| Nitrofurantoin | EDQM, US FDA | 5 |
| Selexipag | SFDA (Saudi Arabia), US FDA | 5 |
| Mirtazapine | EDQM, US FDA | 4 |
| Adapalene | EDQM, US FDA | 2 |
| Brimonidine | EDQM, US FDA | 2 |
| Carbidopa | EDQM, US FDA | 2 |
| Carbimazole | EDQM, US FDA | 2 |
| Chlorthalidone | EDQM, US FDA | 2 |
| Dapoxetine | SFDA (Saudi Arabia), US FDA | 2 |
| Doxycycline | US FDA | 2 |
| Esketamine | EDQM, US FDA | 2 |
| Foscarnet | EDQM, US FDA | 2 |
| Ketamine | EDQM, US FDA | 2 |
| Lercanidipine | US FDA | 2 |
| Lercanidipine Hydrochloride | EDQM | 2 |
| Levodopa | EDQM, US FDA | 2 |
| Lithium Cation | US FDA | 2 |
| Mesalazine | EDQM, US FDA | 2 |
| Methimazole | EDQM, US FDA | 2 |
| Potassium | US FDA | 2 |
| Voriconazole | US FDA | 2 |
| Abrocitinib | US FDA | 1 |
| Avacopan | US FDA | 1 |
| Besifloxacin | US FDA | 1 |
| Cenobamate | US FDA | 1 |
| Daridorexant | US FDA | 1 |
| Deutetrabenazine | US FDA | 1 |
| Dexmedetomidine | US FDA | 1 |
| Docosanol | US FDA | 1 |
| Efinaconazole | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| CDSCO (India) | 2 | None |
| US FDA | None | 1 |
| EMA | None | 1 |
| Year | Revenue | Exports | Destinations |
|---|---|---|---|
| 2026 YTD | Not reported | $1.6M | 18 |
| 2025 | Not reported | $7.3M | 37 |
| 2024 | Not reported | $4.5M | 41 |
| 2023 | Not reported | $5.7M | 33 |
Export figures are customs aggregates. We do not publish the identity of any buyer.
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