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.|
|Ondansetron hydrochloride dihydrate||√||√||√||103639-04-9|
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.
|Sitagliptin phosphate monohydrate||654671-77-9|
|Dabigatran etexilate mesylate||√||√||593282-20-3|