As first reported on Sept. 16, Ranbaxy Laboratories, a subsidiary of Daiichi Sankyo Company Ltd. and a member of the Daiichi Sankyo Group, has received communication from the U.S. Food and Drug Administration about an Import Alert imposed on its Mohali, India, plant following an FDA inspection in late 2012. The FDA has also advised Ranbaxy that the Mohali plant will be subject to certain terms of the Consent Decree filed in late January 2012 for the Paonta Sahib and Dewas Plants in India. Consequently, Ranbaxy is currently assessing its terms and practical applications for the Mohali plant.
According to the terms of the Consent Decree for the Paonta Sahib and Dewas plants, Daiichi Sankyo, together with Ranbaxy, has committed to further strengthening Ranbaxy’s procedures and policies to ensure data integrity and comply with current good manufacturing practices. Moreover, based on the communication from FDA last week, Daiichi Sankyo is also further and fully committed to supporting these extensive activities, both quantitatively and qualitatively, to enhance and uphold the highest quality standards, and we will fully cooperate with the U.S. authorities, taking any and all necessary steps to resolve their concerns.
Daiichi Sankyo is aiming for the expansion and enhancement of Group business results revolving around collaboration with Ranbaxy as one of the Group’s management goals. Based on this resolve, we continue to contribute to providing high-quality pharmaceuticals to the patients who need them around the world.
Date: September 24, 2013
Source: Daiichi Sankyo