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华海药业:关于制剂产品盐酸双环胺片获得美国FDA批准文号的公告
Core Viewpoint - Huahai Pharmaceutical announced the approval of its abbreviated new drug application (ANDA) for Dihydrocodeine Hydrochloride Tablets by the U.S. FDA, which is a significant milestone for the company [1] Group 1 - Huahai Pharmaceutical received notification from its subsidiary, Pulinsitong Pharmaceutical Co., Ltd., regarding the FDA approval [1] - The approved product is Dihydrocodeine Hydrochloride Tablets, which indicates the company's expansion into the U.S. generic drug market [1]
华海药业:盐酸双环胺片获得美国FDA批准文号
Mei Ri Jing Ji Xin Wen· 2025-08-28 08:48
Core Viewpoint - Huahai Pharmaceutical's subsidiary has received FDA approval for a new drug application for Dicyclomine Hydrochloride Tablets, which is expected to enhance its market presence in the U.S. [1] Group 1: Company Developments - The subsidiary, Pulinsitong Pharmaceutical Co., Ltd., has successfully obtained approval for the abbreviated new drug application (ANDA) from the U.S. FDA [1] - The drug is primarily used for treating functional gastrointestinal disorders and was developed by ALLERGAN SALES LLC, first launched in the U.S. in 1984 [1] - The company has invested approximately 7 million RMB in research and development for this project [1] Group 2: Market Impact - The expected sales revenue for the drug in the U.S. market in 2024 is approximately 17.6 million USD [1] - The approval allows the company to sell the product in the U.S. market, which is anticipated to expand its sales and strengthen its product supply chain [1] - This development is expected to enrich the company's product portfolio and enhance its market competitiveness [1]