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news.Claris Lifesciences, based in India, has announced that the USFDA has completed the evaluation of the corrective actions taken at its plant in Ahmedabad and approved the resumption of exports to the American market.
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On 1 November 2010, the US regulatory body issued a warning letter to the company along with an import alert for violation of approved manufacturing norms at the company’s Ahmedabad facility and also banned import of products manufactured at the plant to the US.
Claris Lifesciences managing director and CEO Arjun Handa said, "We are very happy with this approval and we thank all stakeholders for their support. We look forward to re-entering the United States."
Claris had received seven ANDA approvals across four products before receiving the warning letter.
According to the company, US is the largest market for generic injectable products accounting for 51% of the global market which is also the key area of it’s future growth.