Caplin Point CRO division Amaris Clinicals clears FDA audit
Caplin Point Laboratories Limited said that its clinical research organization (CRO) division — Amaris Clinicals, which is located in Chennai, has wrapped up a virtual audit from the US Food and Drug Administration (FDA) with zero observations.
Amaris Clinical is said to be capable of carrying out clinical studies for submissions with various pharma regulators such as the FDA, WHO, EMA, TGA, and ANVISA among others.
C. C. Paarthipan — Chairman of Caplin Point Laboratories 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 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 Point Laboratories said that it pursues approvals on mutual recognition basis from other regulatory bodies, including those from Latin America, which is an important region for the company.