Amaris Clinicals completes USFDA Audit with NIL observations: Chennai

Considering the potential increase in demand for these activities, we will be expanding capacities at this site shortly."

Documents of medical store
Picture: Pixabay

Last Updated on September 27, 2021 by The Health Master

Amaris Clinicals, the clinical research organization (CRO) division of Caplin Point Laboratories Limited, located at Chennai, has completed a virtual audit from 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.”

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

Amaris Clinical is a highly automated state of the art clinical research organization capable of performing clinical studies for submissions with various Regulators like USFDA, EMA, WHO, TGA, ANVISA, etc.

Lupin gets these 7 observations from USFDA for Goa Plant

USFDA inspection ends with ‘Zero’ observations: Alkem

Alkem gets two observations from USFDA for USA plant

Dr Reddy’s gets 3 observations from USFDA for US-based API plant

Alembic Pharma gets 5 observations from

Lupin gets 13 observations post USFDA inspection

World Pharmacists Day: Salute to all Pharmacists – The Backbone of…

Gujarat is in the process of setting up a world class…

DCGI nod to BDR Pharma for drug to treat various infections

APTI asks PCI to fix pay scale for Pharmacy Teachers as…

AIOCD opposes installation of CCTV cameras in all Medical Stores

Latest Notifications regarding Pharmaceuticals

For informative videos by The Health Master, click on the below YouTube icon:

YouTube Icon
YouTube Icon

Enter your email address:

Delivered by FeedBurner