India’s Claris Lifesciences Gets MHRA Approval for Manufacturing Plant

Claris Lifesciences, a sterile injectable pharmaceutical company based in Ahmedabad, India, has received approval from the UK’s Medicines and Healthcare products Agency (MHRA) for a newly commissioned plant in Ahmedabad. The approval is for terminally sterilization products manufactured in glass ampuls in Line 1 of the plant.

The company has plans to install another line in this plant, which will be ready for commercial production by the end of this year. The existing line has capabilities to manufacture aseptic sterilized products, and the new line will have the capability to manufacture lyophilized products. The company’s other flagship plant in Ahmedabad is already approved by the MHRA. Overall, company has three manufacturing facilities at a campus located in Ahmedabad.

The expansion is part of the company’s strategy to increase its position in regulated markets, particularly the European Union. As of June 2014, the company had approvals of 13 abbreviated new drug applications (ANDAs) in the US, 14 molecules in European markets, and 11 molecules in other regulated markets. It has filed and is awaiting regulatory approval for 28 ANDAs in the US, eight marketing applications in Europe, and 10 applications in other regulatory markets.

Source: Claris Lifesciences

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