Granules India is an API and finished-dose manufacturer based in India. It holds 95 active US drug master files and 42 valid CEPs. Its filings concentrate with US FDA, INVIMA (CO) and MINSA (CR). Its GMP standing is certified by EMA, US FDA and MFDS (Korea), among 5 authorities. Its most recent recorded inspection, by US FDA, closed on 20 June 2025 as VAI. Customs aggregates show $79.7M of exports covering 1,157 molecules to 62 destinations in 2025.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| TELANGANA, India | Not on file |
| Hyderabad, India | Not on file |
| Sangareddy, India | 3003723146 |
| Anakapalli, India | 3012884557 |
| Medchal-Malkajgiri District, India | 3004097901 |
| Visakhapatnam, India | Not on file |
4 further sites are on record.
| Molecule | Regulators | Docs |
|---|---|---|
| Rifaximin | EDQM, US FDA | 8 |
| Guaifenesin | EDQM, SFDA (Saudi Arabia), US FDA | 7 |
| Esomeprazole | EDQM, US FDA | 6 |
| Gamma-Hydroxybutyric Acid | US FDA | 6 |
| Metoprolol | EDQM, US FDA | 6 |
| Omeprazole | EDQM, US FDA | 6 |
| Acetaminophen | EDQM, SFDA (Saudi Arabia), US FDA | 5 |
| Dasatinib | US FDA | 4 |
| Levetiracetam | EDQM, US FDA | 4 |
| Metformin | EDQM, US FDA | 4 |
| Metformin Hydrochloride | EDQM | 4 |
| Penicillamine | EDQM, US FDA | 4 |
| Pirfenidone | EDQM, US FDA | 4 |
| Sorafenib | EDQM, US FDA | 4 |
| Trazodone | EDQM, US FDA | 4 |
| Abemaciclib | US FDA | 2 |
| Atazanavir | US FDA | 2 |
| Atazanavir Sulfate | EDQM | 2 |
| Avatrombopag | US FDA | 2 |
| Bortezomib | US FDA | 2 |
| Bupropion | US FDA | 2 |
| Cetirizine | US FDA | 2 |
| Cetirizine Dihydrochloride | EDQM | 2 |
| Dapagliflozin | US FDA | 2 |
| Dimethyl Fumarate | US FDA | 2 |
| Eltrombopag | US FDA | 2 |
| Empagliflozin | US FDA | 2 |
| Fexofenadine | US FDA | 2 |
| Fruquintinib | US FDA | 2 |
| Gabapentin | US FDA | 2 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| US FDA | 108 | 5 |
| INVIMA (CO) | 24 | None |
| MINSA (CR) | 14 | None |
| Health Canada | 5 | None |
| SFDA (Saudi Arabia) | 1 | None |
| DIGEMAPS (DO) | 1 | None |
| EMA | None | 7 |
| MFDS (Korea) | None | 4 |
| CDSCO (India) | None | 3 |
| ANVISA (Brazil) | None | 2 |
| Year | Revenue | Exports | Destinations |
|---|---|---|---|
| 2026 YTD | $626.9M | $45.2M | 52 |
| 2025 | $523.6M | $79.7M | 62 |
| 2024 | $540.3M | $59.4M | 58 |
| 2023 | Not reported | $115.5M | 61 |
Export figures are customs aggregates. We do not publish the identity of any buyer.
Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.
Choose your molecules and target markets. Granules India comes back tiered against every other supplier able to file there.
Start for freeRanked by shared active ingredients where we have them, otherwise by country and comparable credentials.