HIKAL Ltd.

APIs and Intermediates

APIs and Intermediates

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.

Human Health APIs

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.