Lotus Pharmaceutical Co., Ltd (“Lotus” or “the Company”, Taiwan OTC stock code: 1795) today announced that its ANDA (“Abbreviated New Drug Application”) of Levonorgestrel for contraceptive has been officially approved by US FDA. The Company will start the preparation for product launch in the US market accordingly.
Levonorgestrel is a female hormone product for contraceptive, which requires high potency hormone production facilities in an independent with strict standards area for manufacturing. Lotus’ production facilities in Nantou Taiwan have been approved by US FDA, EU EMA, Japan PMDA as well as Taiwan TFDA, and it has the capability of manufacturing the hormone products for the US market by itself. Besides the approved ANDA of Levonorgestrel 1.5mg Tablet, Lotus has 7 more ANDA filings submitted while waiting for US FDA approvals in pipeline.