Claris Lifesciences received the UK MHRA approval for its newly commissioned plant (plant 2). This will help in enhancing capacities to grow in the regulated markets, especially the European Union. The company’s specialty injectables business saw a growth of 30 per cent in the last quarter.
As on 30th June 2014, the company had approvals of 13 ANDAs in US, 14 molecules in the Europe and 11 molecules in Other Regulated Markets (ORM), additionally, there are 28 ANDAs in the US, eight molecules in Europe and 10 molecules in ORM, which are filed and awaiting approval. The company is currently functioning at high capacity utilisation and is adding capacities in Plant 2 to service future demands. To sustainably grow, attaining the required regulatory approvals is one of the key growth drivers; and the company has a large pipeline of products; which includes the under approval and the products currently under development.
The company’s flagship plant (Plant 1) is already approved by UK MHRA. This is the first regulatory inspection and compliance approval conducted by UK MHRA in line with the EU GMP regulations for Plant 2, this approval is for terminally sterilised products presented in glass ampoules manufactured in Line 1 of the Plant 2.
It 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 sterilised products as well, and the new line will have the capability to manufacture lyophilised products.
EP News Bureau- Mumbai
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