Claris Lifesciences gets UK MHRA’s nod for its plant

01 Aug 2011 Evaluate

Claris Lifesciences has received United Kingdom Medicines and Healthcare Product Regulatory Agency (UK MHRA) approval for its plant. With this approval, the company can re-launch its Bag Products in the European Union (EU). This approval is a big step towards resolving the Bag issue in totally.

The company had recalled three of its products sold in bags from the US in June 2010. Post this recall the MHRA had inspected the Claris plant Ahmedabad on 4th- 8th of October 2010. This approval will benefit the company as EU is a lucrative market both in terms of revenue and margins. The European Union with about 24 percent of the global injectables market is the second largest market in the world, second only to the United States.

Earlier in June, the company had received an in-principle approval for its block buster drug ‘Propofol’ in the European Union (EU). This allowed the company to process the registration across 25 countries in the EU.

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