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news.The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Claris Lifesciences’ newly commissioned facility (Plant 2).
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The latest approval will pave for Cbris Lifesciences to improve capacities to develop in the regulated markets, mainly the European Union.
By the end of June, Cbris had received approvals for 13 Abbreviated New Drug Applications (ANDA) in the US, 14 molecules in the Europe and 11 in Other Regulated Markets (ORM).
Further, there are 28 ANDAs in the US, eight molecules in Europe and 10 in ORM, which are filed and yet to be approved.
Cbris is already running at high capacity and is further adding capacities in Plant 2 to cater future demands.
The Company’s flagship plant (Plant 1) has already been approved by MHRA.
The latest approval intends for Terminally Sterilized products deployed in glass ampoules produced in Line 1 of the Plant 2, while the company is also planning for another line at the new facility (Plant 2) which will be ready for commercial production by the end of 2014.
The existing line is also assigned to produce Aseptic Sterilized products, with the new line will be aimed at manufacturing Lyophilized Products.