Earlier this year, Chairman of the US-China Economic and Security Review Commission (USCC) described US Food and Drug Administration efforts to inspect almost 4,000 Chinese facilities that produce APIs for the US market as a “hopeless task.”
Despite plans to increase the number of inspectors , the US would be forced to rely on China’s own enforcement regime, Shea said in April. However, the tightening of GMP requirements in China should help ensure quality and reduce the overall number of API makers, according to Portia Lin, Vice President of Marketing and Sales at ScinoPharm.
“We believe that to cope with the latest GMP requirements, China pharma companies face stiff challenges,” she told in-Pharmatechnologist.com. “In the 12th five-year plan [2011-2015] , the Government not only explicitly requires 100% compliance with the latest GMP for nationwide pharma manufacturing, but also encourages pharma companies to apply for international certifications.”
The Chinese FDA issued final notice on mandatory Good Manufacturing Practice (GMP) inspections in 2011 and “the companies who comply with the latest GMP standards will benefit from the reduced competition after the 12th five-year plan drives out disqualified companies,” Lin continued.
Lin’s comments were mirrored by audit firm Deloitte who, in a 2011 report , predicted costs associated with greater compliance would push out smaller manufacturers.
China and Taiwan
According to the US FDA’s online database, eleven plants in China, Taiwan and Hong Kong have received warning letters since January 2012 , the latest being API maker Zheijiang Jiuzhou Pharmaceutical last month.
“Actually API companies from Taiwan enjoy a great track record and don’t have the problems like this,” Lin told us. “Most of the quality issues happen in Chinese and India API companies.”
ScinoPharm is a Taiwan-headquartered Contract Research and Manufacturing (CRAM) services firm but has a site in Changshu, China. The company recently opened an API manufacturing plant on the site which the firm said was the first plant in China built to the new GMP regulations.
“This plant will serve as the base for our company to develop its API business in China,” Lin explained. “The Changshu plant can also serve as a primary link for companies desiring to supply pharmaceutical products from China to the American and European markets given ScinoPharm’s high quality production capability and our vast international experiences.”