Caraco Pharmaceutical Laboratories, the Detroit-based generic subsidiary of Sun Pharmaceuticals Ltd., has been issued a letter of warning by the US Food and Drug Administration (FDA), and all its future marketing approvals for medicines have been withheld due to some quality-control issues.

This action of the US regulator comes in the wake of certain technical inadequacies identified by it during a May 2008 inspection. The FDA considered some of its observations to be repeat observations, and hence issued the warning letter.

Caraco said the FDA observations include, among other things, the inadequate and untimely investigation by the quality control unit of certain incidents at the facility contrary to the company’s standard operating procedures.

The Company said it is committed to working cooperatively and expeditiously with the FDA to resolve the matters indicated in its letter. It intends to respond promptly and timely to the FDA within fifteen business days. 

Sun spokesperson said: “Sun has 96 such applications pending before FDA and all other products are to be sourced from our other manufacturing facilities in the US and India.”

Among Indian companies, Sun pharma has maximum exposure to the US market with over 40 per cent of its revenues coming from medicine sales in the US. However, the FDA move will not have a major impact on India’s US revenues as all its products, currently marketed in the country will continue to be sold in the US – in fact, of the pending marketing approvals from US FDA only 19 products are from Caraco.