Orient Europharma Provides Update on Progress of Approval and Commercialization of Fortacin in Taiwanese, Hong Kong and Macau
June 18, 2020 at 04:31 am
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Orient Europharma, the Regent Pacific Group Limited's commercial strategic partner for Taiwan, Hong Kong, Macau and certain other countries in South East Asia, has received the first deficiency letter from the Taiwan FDA ("TFDA") in respect of its application for FortacinTM and it has completed and sent back its response and supporting documents on 16 June 2020. TFDA has recently approved the DMFs for lidocaine and prilocaine the active pharmaceutical ingredients of FortacinTM. On the assumption that TFDA does not have any further questions/deficiencies, Orient Europharma anticipates approval around January 2021, which would trigger a payment of USD 300,000 (or approximately HKD 2.34 million) to the Group.
Orient Europharma Co., Ltd. is principally engaged in the manufacture and distribution of nutritious healthcare products and medical cosmetic products, as well as western drugs. The Company operates nutritious healthcare products and medical cosmetic products segment, providing infant milk powders, nutritious products and functional healthcare products, as well as dermatological preparations, medical hair care series, organic skin care series and medical make-up products, among others; western drugs segment, providing products for cardiovascular diseases, cancer, blood diseases, diabetes, central nervous system diseases and asthma, among others.