Daiichi to cooperate with USFDA to resolve Ranbaxy concerns

USFDA issued an import alert on drugs produced by the company's Mohali plant

Japanese drug major Daiichi Sankyo will work with US authorities to resolve the issue of a ban imposed by the USFDA on the import of drugs from the Mohali plant of its Indian unit Ranbaxy Laboratories.

 

"...We will fully cooperate with the US authorities, taking any and all necessary steps to resolve their concerns," Daiichi Sankyo said in a statement today.

 

On September 16, the US Food and Drug Administration (USFDA) issued an import alert on drugs produced by the company at its Mohali plant in Punjab for violation of current good manufacturing practices.

 

This was the company's third facility, after the Paonta Sahib (Himachal Pradesh) and Dewas (Madhya Pradesh) plants, to have been banned from exporting drugs to the US for violation of current good manufacturing norms.

 

The USFDA has advised Ranbaxy that the Mohali plant will be subject to certain terms of a consent decree filed in late January 2012 for the Paonta Sahib and Dewas plants, Daiichi said in a statement.

 

Consequently, Ranbaxy is currently assessing its terms and practical applications for the Mohali plant, it added.

 

Based on the communication from USFDA 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, it said.

 

In May, Ranbaxy pleaded guilty to "felony charges" related to the manufacture and distribution of certain 'adulterated' drugs made at the Dewas and Paonta Sahib units and agreed to pay $500 million to US authorities as penalty.

 

This followed a series of actions by the USFDA, which in 2008 banned the import of 30 generic drugs produced by Ranbaxy at the two plants for violation of manufacturing norms.

 

Despite the setbacks, Daiichi Sankyo said it "is aiming for the expansion and enhancement of group business results revolving around collaboration with Ranbaxy as one of the group's management goals."