Hikal manufactures APIs and intermediates for global innovator companies. Our capabilities in chemistry have shaped a product portfolio through non-infringing processes. Our state-of-theart cGMP manufacturing facilities coupled with robust supply chain management enable us to serve global innovator and life sciences companies.
Hikal has a 20 years+ track record of developing APIs in a dynamic regulatory landscape. We have regulatory approvals from the US FDA-cGMP, TGA-GMP, KFDA (Korea), PMDA (Japan), AFMPS (Belgium), EDQM, EPA, COFEPRIS (Mexico). We rank in a select list of Indian companies with zero 483 observations after US FDA audits of API and intermediate manufacturing facilities.
Hikal has a significant scale up capacity with backward integration capability. Our robust systems, quality and regulatory focus ensure that you benefit from customized APIs.
| Therapeutic Category | Product Name | USDMF | EDMF | CEP | CAS No. |
|---|---|---|---|---|---|
| Anti-convulsant | Gabapentin # | √ | √ | √ | 60142-96-3 |
| Pregabalin | √ | √ | √ | 148553-50-8 | |
| Anti-emetic | Ondansetron | √ | √ | 99614-02-5 | |
| Ondansetron hydrochloride dihydrate | √ | √ | √ | 103639-04-9 | |
| Anti-histaminic | Triprolidine hydrochloride | √ | √ | 6138-79-0 | |
| Anti-depressant | Bupropion hydrochloride | √ | √ | 31677-93-7 | |
| Venlafaxine hydrochloride | √ | √ | √ | 99300-78-4 | |
| Anti-psychotic | Quetiapine fumarate | √ | √ | 111974-72-2 | |
| Memantine hydrochloride | √ | √ | 41100-52-1 | ||
| Anti-lipemic | Gemfibrozil | √ | √ | √ | 25812-30-0 |
| Hemorheological | Pentoxifylline | √ | √ | √ | 6493-05-6 |
Hikal has a long API product pipeline to accelerate new product development and sustain your competitiveness. We have rich experience in developing innovative routes using breakthrough technologies such as enzymatic and / or flow chemistry. Hikal proposes to file about six to eight drug master files (DMFs) every year and build a robust product pipeline across therapeutic areas.
| Category | Product | USDMF | EDMF | CEP | CAS No. |
|---|---|---|---|---|---|
| Anti-diabetic | Vildagliptin | √ | √ | 274901-16-5 | |
| Sitagliptin phosphate monohydrate | 654671-77-9 | ||||
| Sitagliptin hydrochloride | 1115-70-4 | ||||
| Canagliflozin | √ | 842133-18-0 | |||
| Dapagliflozin | 461432-26-8 | ||||
| Empagliflozin | 864070-44-0 | ||||
| Ertugliflozin | 1210344-57-2 | ||||
| Anti-thrombotic | Apixaban | 503612-47-3 | |||
| Dabigatran | 211915-06-9 | ||||
| Dabigatran etexilate mesylate | √ | √ | 593282-20-3 | ||
| Rivaroxaban | 366789-02-8 | ||||
| Anti-hypertensive | Olmesartan medoxomil | √ | √ | 144689-63-4 | |
| Anti-inflammation | Celecoxib | √ | √ | 169590-42-5 | |
| Tolfenamic Acid | 13710-19-5 | ||||
| Analgesic | Butorphanol Tartrate | √ | √ | 42408-82-2 |
