US FDA lifts ban on Claris Lifesciences drugs; shrs jump

Moneycontrol Bureau

Shares of Claris Lifesciences hit a new high on Tuesday after the company said US Food and Drugs Administration has formally lifted a ban on its products, which was imposed in 2010 due to manufacturing quality issues at its plant. This will now allow the Ahmedabad-based company sell its drugs in the United States. "Claris Lifesciences has formally received the letter from US FDA. The letter states that the US FDA has completed its evaluation of the firm's corrective actions in response to their warning letter dated Nov 1, 2010. Based on their evaluation, the US FDA vide their letter dated Aug 14, 2012, confirmed that the violations contained in the warning letter have been addressed," it said on Tuesday. In a warning letter dated Nov 1, 2010 US FDA had pointed out that during its June 2010 inspection of Claris India, investigators identified significant violations of Current Good Manufacturing Practice regulations for finished pharmaceuticals, and these violations caused products to be adulterated. The close out letter issued by the FDA last week means Claris will now be able to manufacture and sell its products in the US and also receive Abbreviated New Drug Application (ANDA) approvals. Claris Lifesciences said it had received 7 ANDA approvals across 4 products before the warning letter was issued in 2010. It has filed for 32 ANDAs across 21 products, and the estimated US market size of all products is about USD 1 billion, it added. "The United States is the largest market for generic injectibles accounting for about 51% of the global market. This approval will allow the company to file more products in this lucrative market, which is considered a key region for the future growth of the company," Claris said. The stock jumped over 10% post the announcement to a 52-week high of Rs 244.30. At 13:00 hrs, Claris was at Rs 226.90, up 4.3% on BSE. The company's shares have risen 34% in the last week. Also Read: Morgan Stanley buys 5 lakh shares of Claris Life Nachiket Kelkar
nachiket.kelkar@network18online.com