Strides clarifies on FDA alert

Bangalore, October 07, 2014 – Strides Arcolab has clarified that it has no role in distributing certain products manufactured by its subsidiary and that these products found its way into the US markets without their knowledge.

Earlier in the day, the US FDA had, on its Website, expressed concerns about certain products manufactured by Strides’ subsidiary Beltapharm SpA. “Beltapharm has only one ANDA-approved product, namely Imiquimod Cream, for the US market,” said a spokesperson from Strides.

This skin cream was meant for the African markets but found its way into the grey market, and the company has no knowledge of how this happened, the spokesperson added. Imiquimod is used to treat certain skin growths or tumours. This cream changes the immune response in a human body, helps to kill abnormal cells or stop their growth, but it is not a cure, according to a report by the American Cancer Society. Business Line