Daiichi Sankyo, the Japanese majority stakeholder of Ranbaxy Laboratories, said it will work with the US Food and Drugs Administration (FDA) to resolve drugs quality issues that resulted in an import ban imposed on Ranbaxy’s Mohali plant last week.
“We will fully co-operate with the US authorities, taking any and all necessary steps to resolve their concerns,” Saiichi said in a statement on Tuesday.
Import alert
The import alert issued by FDA on drugs made at Ranbaxy’s Mohali plant on September 16 came close on the heels of the $500-million legal settlement made by Ranbaxy in the US in May after it pleaded guilty to drug safety violations.
Third plant
Mohali is the third Ranbaxy plant in India to face an import ban for violation of current good manufacturing practices, with Paonta Sahib (Himachal Pradesh) and Dewas (Madhya Pradesh) plants being the other two.
Daiichi also said that the FDA has advised Ranbaxy that the Mohali plant will be subject to certain terms of the consent decree filed for the Paonta Sahib and Dewas plants in late January last year.
To fulfil these terms, “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,” the Japanese drug major said.