For Immediate Release
Company name: DAIICHI SANKYO COMPANY, LIMITED
Representative: Takashi Shoda, President and Representative Director
(Code no.: 4568, First Section, Tokyo, Osaka and Nagoya Stock Exchanges)
Please address inquiries to Toshiaki Sai, General Manager,
Corporate Communications Department
Telephone: +81-3-6225-1126
http://www.daiichisankyo.com/
Daiichi Sankyo's response to recent FDA letter to Ranbaxy(Second Issue)
Tokyo, February 26, 2009 - Daiichi Sankyo Company, Limited ("Daiichi Sankyo") announced today that its affiliate Ranbaxy Laboratories Limited (NSE/BSE: Ranbaxy/500359; Head Office in Delhi, India) ("Ranbaxy") had received a letter and information indicating that all pending and approved ADNAs (Abbreviated New Drug Application) from Ranbaxy's Paonta Sahib facility have been added to a list maintained under a policy entitled 'Application Integrity Policy' or 'AIP'.
The FDA has said that it has no evidence that these drugs do not meet their quality specifications and has not identified any health risks associated with currently marketed Ranbaxy products.
Regarding of ANDAs applied from the factory or all of ANDAs based on the data of the factory,
the letter gives the opportunity to Ranbaxy to co-operate with the agency to address the issues or withdraw the application.
No other products from Ranbaxy's other manufacturing facilities are included in the AIP.
After carefully analyzing the letter and information, Ranbaxy will be responding to the FDA and will continue to co operate with the agency.
Daiichi Sankyo takes the issue very seriously, and both Daiichi Sankyo and Ranbaxy have already formed a team to solve this issue.
End