We assess practical application over Mohali plant fiasco: Daiichi Sankyo

US FDA imposed an import alert on Ranbaxy's Mohali plant following a FDA inspection in late 2012

Daiichi Sankyo Company Limited, the parent company of Ranbaxy has said on Tuesday that Ranbaxy is currently assessing its terms and practical applications for the Mohali plant.

 

US Food and Drug Administration had imposed an import alert  on Ranbaxy's Mohali plant following a FDA inspection in late 2012.

 

In a statement, Daiichi Sankyo sadi that US 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.

 

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, company said.

 

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 US authorities, taking any and all necessary steps to resolve their concerns, added the statement.