Lotus Pharmaceutical Co., Ltd (“Lotus” or “the Company”, Taiwan OTC stock code: 1795) today received an official notice from US FDA indicating that its manufacturing facilities in Nantou once again passed US FDA’s general inspection. This is the third time that Lotus successfully passed US FDA’s inspection.
In order to expand the export business with strengthened product portfolio, Lotus has continuously improved the quality of manufacturing to ensure the safety of production since the establishment of Nantou plant. With the superior manufacturing facilities approved by all US FDA, EU EMA, Japan PMDA as well as Taiwan TFDA, Lotus has the capability of manufacturing and marketing its products to highly regulated markets including US, EU, and Japan, by itself and at the same time focuses on the development and production of difficult-to-make generics at the highest quality standard.
Lotus also has a solid portfolio pipeline to further strengthen its export business globally. For US market, in addition to Mefenamic Acid Capsule 250mg and Levonorgestrel Tablet 1.5mg which are already launched to the US market, Lotus has obtained a tentative approval for Paricalcitol Capsules and 6 more ANDA filings submitted while waiting for US FDA approvals. As for Japan market, Lotus has successfully launched TS-1 and has been working with local partners for several R&D projects to continue the growth momentum.