Caraco Pharma not to manufacture from Detroit by FY11 end

Based on remediation efforts to date, Detroit-based Caraco Pharmaceutical Laboratories, a subsidary of Sun Pharmaceutical, said that it does not expect to commence the manufacture and distribution of products from its Detroit facility by the end of FY11. The company had said earlier that two products would commence manufacture in the Detroit facility prior to the end of fiscal 2011.The company's remediation steps yet to be completed for Detroi plant.

Forfeiture and Permanent Injunction entered into with the FDA on September 29, 2009, however, a number of significant steps and processes are yet to be completed. The company will not be able to begin the manufacture and distribution of products by the end of FY11.

Caraco's remediation efforts towards the resumption of manufacturing and distribution from its facilities are still ongoing, but they are unable to predict when such manufacturing and distribution will resume. There is no assurance that the remediation efforts will be successful or result in resolution of the FDA compliance issues.