Claris to go it alone in USA

27 August 2012

Claris Lifesciences, a leading Indian injectable generic pharmaceuticals maker, has said that, following approval by the US Food and Drug Administration of the corrective actions taken at its plant in Ahmedabad, the company can now manufacture and sell its products in the USA. It can also receive Abbreviated New Drug Application (ANDA) approvals, the company added.

In November 2010, the FDA had 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 USA.

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