Claris Lifesciences today said the USFDA has approved the corrective actions taken at its plant in Ahmedabad thereby paving way for resumption of exports to the American market.
The US Food and Drug Administration (USFDA) had on November 1, 2010 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.
"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 Lifesciences Managing Director and CEO Arjun Handa said.
The approval will allow the company to manufacture and sell its products in the US and also receive abbreviated new drug application (ANDA) approvals, the company added.
In a letter on Aug 14, the USFDA had said Claris appeared to "have addressed the violation(s) contained in the warning Letter (of November 1, 2010).
"Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections," it added.
Claris had received seven ANDA approvals across four products before receiving the warning letter.
US is the largest market for generic injectable products, accounting for 51% of the global market, which is also the key area of the company's future growth, the firm said.
The Claris scrip touched a new high of Rs 226.75 in the afternoon trade on BSE, up 4.18% from its previous close.