Welcome to this week's FiercePharmaAsia report, which includes information on China's new ICH membership, Takeda's $111 million solid dosage plant near Berlin, and data integrity problems with an Indian company and a Chinese one.
1. China’s FDA joins ICH as regulatory member (PDF release)
Founded in 1990 by the U.S., European and Japanese drug regulatory authorities, the International Council for Harmonisation has added China’s FDA as a new regulatory member. The decision came after a closed-door meeting of the ICH Assembly in Montreal on June 1, and was released on June 19. The membership is considered a milestone for China as it further aligns itself with drug-related industry standards, the drafting of which it is now actively involved in.
Takeda has completed construction of its new $111 million manufacturing plant in Germany. The facility is part of the company’s plan to streamline global manufacturing of its solid dosage form pharmaceutical products from its Osaka plant to this new Oranienburg plant and a Hikari plant in Japan. The 21,400-square-meter plant will produce drugs in the areas of gastroenterology, central nervous and cardiovascular systems.
The FDA has banned imports from three drug facilities in India operated by Ipca Laboratories. An FDA warning letter sent out in January listed testing data manipulation and falsification of records found in a 2014 inspection as the main reason for the embargo. The only exception was made to a malaria treatment API product until the FDA decides otherwise based on shortage and medical necessity.
The FDA has sent a warning letter to Chinese API maker Qinhuangdao Zizhu Pharmaceutical, which the regulatory agency had placed on import alert earlier. Again, manipulation of test results was the problem. The company was the only WHO prequalified API supplier for birth control drug levonorgestrel.