The FDA’s decision to ban the products of a Chinese API maker has left the World Health Organization in the lurch trying to find another company to supply the ingredient for the birth control drug levonorgestrel.
The FDA recently added Qinhuangdao Zizhu Pharmaceutical to its import alert list, after an inspection last year found data integrity issues at its plant in Qinhuangdao in the Hebei province in China, the WHO reported. FDA Enforcement Reports show the company is recalling all of its APIs from the U.S. market.
Qinhuangdao Zizhu was the only WHO-prequalified supplier of the API levonorgestrel for the two finished pharma products of the birth control tablets that have been approved for use in its programs.
The health organization said in an announcement that it is talking with both Qinhuangdao Zizhu and the FDA about the situation. It also is working with the finished med makers to identify other sources of the API, but at this point has “no alternative levonorgestrel API which has been prequalified.”
As a result, the WHO is asking the suppliers of the finished tablets to continue to produce them with the API from Qinhuangdao Zizhu but to do additional testing on them to assure their quality. It said it has not received any reports of quality issues about the contraceptive.
It also is allowing procurement agencies to continue to buy the pills, or any meds made with the APIs mifepristone and ethinylestradiol from the Chinese company, which also have been prequalified by the WHO.
The World Health Organization intends to send its own inspectors back to the Qinhuangdao Zizhu Pharmaceutical plant for a reinspection. During a visit in 2015 to qualify the company’s products, WHO inspectors reported finding five major deficiencies, including data integrity issues, as well as several minor problems. After the company provided a corrective and preventive action plan to fix the issues, the inspection was closed and Qinhuangdao Zizhu’s products approved for use in WHO-subsidized drugs.