Our Manufacturing Prowess

We have three world-class API manufacturing facilities capable of handling complex and hazardous reactions. The manufacturing facilities comply with all regulatory guidelines and requirements of current Good Manufacturing Practices (cGMP) and have been successfully inspected/approved by international health and regulatory agencies. Our facilities (Unit I and II) have successfully cleared 15 US FDA audits, a testimony to the reliability of our systems and processes. For the recently commissioned Unit-III, we are working with the US FDA to expedite the inspection and the approval for commercial manufacturing of APIs.

Our Research Capabilities

We have a dedicated state-of-the-art R&D facility which has been approved by the Department of Scientific and Industrial Research (DSIR) and inspected by the US FDA in February 2016 without any observations. The facility houses development laboratories, analytical laboratories, a dedicated kilo laboratory for scale-up and a dedicated laboratory for peptides. Our R&D facility has proven its capabilities in carrying out a wide range of reactions, including bringing complex molecules with efficient processes to market; developing non-infringing processes; developing cost-effective routes; reducing impurities levels by better process understanding; and reducing effluent generation.