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Claris Lifesciences receives MHRA approval for newly commissioned plant

21 Aug 2014 Evaluate

Claris Lifesciences has received the MHRA approval for its newly commissioned plant, which will help the company in enhancing capacities to grow in the regulated markets, especially the European Union.

The Company's flagship plant (Plant 1) is already approved by MHRA-UK. This is the first regulatory inspection and compliance approval conducted by MI-IRA-UK in line with the EU GMP regulations for Plant 2, this approval is for Terminally Sterilized products presented in glass ampoules manufactured in Line 1 of the Plant 2.

Further, the company has plans to install another line in this new plant (Plant 2) which will be ready for commercial production by the end of this year. The existing line has capabilities to manufacture Aseptic Sterilized products as well, and the new line will have the capability to manufacture Lyophilized Products. 

Back in June, the company acquired approvals of 13 ANDAs in US, 14 molecules in the Europe and 11 molecules in Other Regulated Markets (ORM). Additionally, the company has 28 ANDAs in the US, 8 molecules in Europe and 10 molecules in ORM, which are filed and awaiting approval.

The company is currently functioning at high capacity utilization and is adding capacities in Plant 2 to service future demands. It has a large pipeline of products; which includes the under approval and the products currently under development.

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