Lotus Pharmaceutical Co., Ltd (“Lotus” or “the Company”, Taiwan OTC stock code: 1795) today announced that its contract development and manufacturing hormonal generics Norethisterone/Ethinylestradiol 1mg/0.035mg tablets has been officially approved by Japan PMDA. Customer of Lotus received the marketing authorization of this drug as the MA holder. The Company will start the preparation for product commercialization of the oral contraceptive drug in Japan with its customer.
Contract development and manufacturing has been the primary business model for Lotus in Japan due to higher market entry barrier. The success of Norethisterone/Ethinylestradiol 1mg/0.035mg tablets has once again fortified the leading position of Lotus in high potency formulations. Lotus will continue to work with its partners in Japan on hormonal product line extension. The Company also expects to introduce more high value hormonal and oncology drugs in Japan following similar partnership pattern.