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Claris gets UK regulatory nod for Ahmedabad plant

03 Aug 2011 Evaluate

Claris Lifesciences Ltd Ahmedabad plant has been approved by the UK's regulatory authority, the Medicines and Healthcare product Regulatory Agency (MHRA). With this approval, Claris can re-launch its bag products in the European Union.  The approval is a step towards resolving the bag issue in totality. Claris had recalled three of its products sold in bags from the US market, in June 2010. Following this recall, the MHRA had inspected the Claris plant in Ahmedabad between October 4-8, 2010.

This approval will benefit Claris as the EU is a lucrative market both in terms of revenue and margins. The European Union with approximately 24 per cent of the global injectable market is the second largest market in the world, after the US. Recently, Claris had received approvals for its flagship product Propofol in the EU. The company has already received 137 approvals in Europe, while another 93 registrations are awaiting approvalscrackcrack

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