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Caplin Point Lab's CRO arm completes USFDA audit with 'nil' observations

In a regulatory filing, Caplin Point Laboratories said Amaris Clinicals located at Chennai, has completed a virtual audit from United States Food and Drug Administration (USFDA) with ''nil'' observations.

September 24, 2021 / 02:19 PM IST

"We remain on track for filing our second product, another oncology biosimilar in the regulated markets, in this calendar year," said Dr. Satakarni Makkapati, CEO of CuraTeQ. [Representative image]

 
 
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Drug firm Caplin Point Laboratories on Friday said the US health regulator has completed a virtual audit of its clinical research organisation division, Amaris Clinicals, and it ended with zero observations.

In a regulatory filing, Caplin Point Laboratories said Amaris Clinicals located at Chennai, has completed a virtual audit from United States Food and Drug Administration (USFDA) with ''nil'' observations.

"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," Caplin Point Laboratories Chairman C C Paarthipan said.

Amaris Clinical is capable of performing clinical studies for submissions to various regulators, Caplin Point Laboratories said in a regulatory filing.

Shares of Caplin Point Laboratories were trading at Rs 890 per scrip on BSE, down 0.59 percent from its previous close.
PTI
first published: Sep 24, 2021 02:20 pm

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