Hikal is an API manufacturer based in India. It holds 32 active US drug master files and 19 valid CEPs. Its filings concentrate with MINSA (CR) and CDSCO (India). Its GMP standing is certified by CDSCO (India), EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 7 February 2025 as OAI. Customs aggregates show $112.7M of exports covering 855 molecules to 55 destinations in 2025.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Bangalore, India | Not on file |
| Bengaluru, India | 3003560263 |
| bengaluru 560 105, India | Not on file |
| Bengaluru, India | Not on file |
| Bharuch, India | 3009627283 |
| Molecule | Regulators | Docs |
|---|---|---|
| Sitagliptin | EDQM, SFDA (Saudi Arabia), US FDA | 5 |
| Bupropion | US FDA | 4 |
| Gabapentin | EDQM, US FDA | 3 |
| Ondansetron | EDQM, US FDA | 3 |
| Pregabalin | EDQM, US FDA | 3 |
| Celecoxib | EDQM, US FDA | 2 |
| Lacosamide | EDQM, US FDA | 2 |
| Memantine | SFDA (Saudi Arabia), US FDA | 2 |
| Pentoxifylline | EDQM, US FDA | 2 |
| Quetiapine | EDQM, US FDA | 2 |
| Rivaroxaban | EDQM, US FDA | 2 |
| Valaciclovir | EDQM, US FDA | 2 |
| Venlafaxine | EDQM, US FDA | 2 |
| Venlafaxine Hydrochloride | EDQM | 2 |
| Apixaban | US FDA | 1 |
| Butorphanol | US FDA | 1 |
| Cariprazine | US FDA | 1 |
| Cinnarizine | EDQM | 1 |
| Dabigatran | US FDA | 1 |
| Dabigatran Etexilate Mesilate | EDQM | 1 |
| Dapagliflozin | US FDA | 1 |
| Desvenlafaxine | US FDA | 1 |
| Edoxaban | US FDA | 1 |
| Empagliflozin | US FDA | 1 |
| Ertugliflozin | US FDA | 1 |
| Flunarizine Dihydrochloride | EDQM | 1 |
| Gemfibrozil | EDQM | 1 |
| Quetiapine Fumarate | EDQM | 1 |
| Triprolidine | US FDA | 1 |
| Vildagliptin | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| MINSA (CR) | 5 | None |
| CDSCO (India) | 2 | 2 |
| EMA | None | 1 |
| US FDA | None | 1 |
| Year | Revenue | Exports | Destinations |
|---|---|---|---|
| 2026 YTD | Not reported | $17.9M | 29 |
| 2025 | $213.5M | $112.7M | 55 |
| 2024 | $213.3M | $108.7M | 60 |
| 2023 | $245.0M | $115.1M | 60 |
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 We do not publish the identity of any buyer.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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