On behalf of WHO, Mr. Vimal SACHDEVA and Mrs. Vassiliki REVITHI inspected Zizhu’s API facilities for Levonorgestrel, Ethinylestradiol and Mifepristone from May 15 to 18, 2012. These three APIs are considered to be manufactured in compliance with WHO GMP, which lays a solid foundation for Zizhu’s FPP prequalification.
On 11-15 June 2012, Mrs. Paula J. Bretz, a US FDA investigator, inspected Zizhu’s API facilities for Levonorgestrel, Ethinylestradiol, Estradiol, Testosterone, Estrone, and Mifepristone. This is the initial US FDA inspection for Zizhu and no FDA 483, “Inspection Observations”, was issued.
The success in achieving WHO and US FDA GMP certification means Zizhu has well- prepared for marketing its products in the overseas market.