Amaris Clinicals clears U.S. FDA audit

The company is the Clinical Research Organisation of Caplin Point Laboratories

The U.S. FDA has completed the virtual audit of Amaris Clinicals, the Clinical Research Organisation division of Caplin Point Laboratories, Chennai with nil observations.

Chairman C. C. Paarthipan said, "It is an excellent milestone for our group, and shows our commitment to maintaining the highest standards of quality and compliance at all our units. In addition to being a profit centre on its own, in the coming years, Amaris will facilitate a cost-effective and quicker foray into newer geographies.’’

He further added, “We plan to expand in areas where BA/BE studies are required for product approvals. Considering the potential increase in demand for these activities, we will be expanding capacities at this site shortly."

The company targets approvals on mutual recognition basis from other regulatory bodies, including ones from Latin America, a key geography for Caplin Point.