Caplin Point's CRO Amaris Clinical completes USFDA audit with nil observations

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

Sep 24, 2021 05:09 IST India Infoline News Service

Caplin Point
Caplin Point Laboratories' Clinical Research Organization (CRO) division, Amaris Clinicals (Amaris) has completed a virtual audit from the United States Food and Drug Administration (USFDA) with NIL observations.

Chairman C. C. Paarthipan commented “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 cost-effective and quicker foray into newer geographies we plan to expand, 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.”

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

On Sensex, Caplin finished at Rs889.90 per piece down 0.6%. 

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