SMS Pharmaceuticals is an API and finished-dose manufacturer based in India. It holds 37 active US drug master files and 22 valid CEPs. Its filings concentrate with NPRA (MY), CDSCO (India) and MCAZ (ZW). Its GMP standing is certified by US FDA and EMA. Its most recent recorded inspection, by US FDA, closed on 12 December 2025 as OAI. Customs aggregates show $34.6M of exports covering 387 molecules to 50 destinations in 2025.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Vizianagaram, India | 3008654585 |
| Hyderabad, India | 3003971663 |
| Hyderabad, India | 3014615000 |
| Molecule | Regulators | Docs |
|---|---|---|
| Ibuprofen | EDQM, US FDA | 6 |
| Famotidine | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Pantoprazole | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Aripiprazole | EDQM, SFDA (Saudi Arabia), US FDA | 3 |
| Ondansetron | EDQM, SFDA (Saudi Arabia), US FDA | 3 |
| Rizatriptan | EDQM, SFDA (Saudi Arabia), US FDA | 3 |
| Eletriptan | US FDA | 2 |
| Itraconazole | EDQM, US FDA | 2 |
| Lamivudine | EDQM, US FDA | 2 |
| Lamotrigine | EDQM, US FDA | 2 |
| Levetiracetam | EDQM, US FDA | 2 |
| Pirfenidone | EDQM, US FDA | 2 |
| Ranitidine | EDQM, US FDA | 2 |
| Sildenafil | EDQM, US FDA | 2 |
| Solifenacin Succinate | EDQM, US FDA | 2 |
| Sumatriptan | US FDA | 2 |
| Tadalafil | EDQM, US FDA | 2 |
| Vardenafil | EDQM, US FDA | 2 |
| Almotriptan | US FDA | 1 |
| Almotriptan Malate | EDQM | 1 |
| Apixaban | US FDA | 1 |
| Clozapine | US FDA | 1 |
| Deferasirox | US FDA | 1 |
| Dexibuprofen | US FDA | 1 |
| Efavirenz | US FDA | 1 |
| Escitalopram | US FDA | 1 |
| Hydroxychloroquine | US FDA | 1 |
| Imidapril | US FDA | 1 |
| Molnupiravir | US FDA | 1 |
| Paliperidone | SFDA (Saudi Arabia) | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| NPRA (MY) | 142 | None |
| CDSCO (India) | 7 | None |
| MCAZ (ZW) | 6 | None |
| BOMRA (BW) | 2 | None |
| BRELA (TZ) | 1 | None |
| NMRC (NA) | 1 | None |
| US FDA | None | 2 |
| EMA | None | 2 |
| Year | Revenue | Exports | Destinations |
|---|---|---|---|
| 2026 YTD | Not reported | $1.6M | 24 |
| 2025 | $89.9M | $34.6M | 50 |
| 2024 | $84.7M | $36.1M | 40 |
| 2023 | $63.2M | $35.5M | 44 |
Export figures are customs aggregates. We do not publish the identity of any buyer. Revenue shown in US dollars, converted from the reported currency.
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