April 13, 2010 
Press Release 
Mitsubishi Tanabe Pharma Corporation
Notice Regarding Administrative Action Related to   
Violation of Pharmaceutical Affairs Law 
 
Today, Mitsubishi Tanabe Pharma Corporation and its subsidiary Bipha Corporation 
(Izumisawa 1007-124, Chitose, Hokkaido; hereafter, Bipha) received an administrative 
action, suspension of business and an order for improvement, from the Ministry of 
Health, Labour and Welfare in regard to a violation of the Pharmaceutical Affairs Act.     
 
The reasons for the action included (1) the fact that the company, a manufacturer and 
marketer, manufactured and sold the ethical drugs "Medway Injection 5%" and 
"Medway Injection 25%" without ensuring that Bipha, the manufacturer, appropriately 
implemented manufacturing control and quality control, and (2) the fact that the NDA 
materials for those products that were submitted by the two companies contained 
materials that were based on fraudulent acts by Bipha. The details of the action are 
that the Company must suspend its first-class pharmaceutical manufacturing and sales 
operations for 25 days, from April 17, 2010 to May 11, 2010 and Bipha must suspend 
its pharmaceutical manufacturing operations for 30 days, from April 14, 2010 to May 13, 
2010. The Company and Bipha have also been ordered to submit business 
improvement plans. 
 
The Company and Bipha are taking this administrative action very seriously, and we 
offer our sincere apologies to patients, medical professionals, and the rest of society.   
 
On March 24, 2009, the Company announced its decision to withdraw the marketing 
authorization for "Medway Injection 5%" and to voluntarily recall "Medway Injection 5%" 
and "Medway Injection 25%" from the market. Currently, all of the products that were 
shipped have been recalled. In addition, we have not received any reports of health 
problems resulting from this incident. 
 
The Company has established the in-house Medway Issue Countermeasures 
Committee. This committee has thoroughly investigated the facts and the cause of the 
incident and has considered how to prevent a recurrence of such an incident. 
Furthermore, to ensure objectivity and independence, the Company has asked outside 
experts to establish the Medway Issue Outside Investigation Committee. This 
committee has worked toward the goal of investigating recurrence countermeasures 
and offering advice. Currently, the Company received the final report from the 
committee.
The Group will work to prevent a recurrence by reemphasizing the importance of 
strictly observing GMP, ensuring the reliability of materials used in support of 
applications, and ensuring rigorous compliance with other pharmaceutical related 
regulations throughout the Group. As employees and managers of a pharmaceutical 
enterprise in a life-related industry, everyone at the Company will work earnestly to 
prevent a recurrence, and we will do our utmost to regain the trust of society.   
 
The influence of this incident on results is currently being considered and will be 
disclosed as soon as it is confirmed.
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For Details, Contact the Following Section
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Corporate Communications Dept., Mitsubishi Tanabe Pharma Corporation 
Tel +81-6-6205-5211