Claris Lifesciences has formally received a letter from The Food and Drug Administration of United States of America (US FDA), which states that the US FDA has completed its evaluation of the firm’s corrective actions in response to their Warning Letter WL: 320-11-003, dated November 1, 2010. Based on their evaluation, the US FDA has; vide their letter dated August 14, 2012; confirmed that the violation(s) contained in the Warning Letter have been addressed.
Claris had received seven ANDAs approvals across four products before the warning letter was issued. The company has filed for a total of 32 ANDAs across 21 products which includes niche products like propofol and iron sucrose. The estimated market size of all products in the US is approximately $1 billion.
The company continues to develop additional generic injectable products for the regulated markets including the US. This approval will allow the company to manufacture and sell its products into the US and also receive ANDA approvals. Protocol Link, a global project management firm providing compliance management, quality systems, regulatory affairs and validation services for FDA-regulated companies, assisted Claris in the process of remediation.
The US is the largest market for generic injectables accounting for about 51 per cent 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.
“We are happy with this approval and we thank all stake holders for their support. We look forward to re-entering the US,” said Arjun Handa, MD and CEO, Claris Lifesciences.