NKF(SH:603707) Zhong Guo Zheng Quan Bao - Zhong Zheng Wang·2025-12-04 08:49Core Points - The company, Nanjing Jianyou Biochemical Pharmaceutical Co., Ltd., has received ANDA approval from the U.S. FDA for its Propofol Emulsion Injection in three specifications: 200 mg/20 mL, 500 mg/50 mL, and 1,000 mg/100 mL [1][2][3] - The reference formulation for Propofol Emulsion Injection is held by Fresenius Kabi USA LLC, which was approved by the U.S. FDA in June 1996 under the brand name DIPRIVAN [2] - Currently, there are eight other manufacturers in the U.S. that have approved generic versions of Propofol Emulsion Injection [2] - The company has invested approximately RMB 73.66 million in the research and development of the Propofol Emulsion Injection project [2] - The newly approved product is expected to be launched in the U.S. soon, which is anticipated to have a positive impact on the company's operating performance [2] Drug Information - Drug Name: Propofol Emulsion Injection [3] - Indication: General anesthesia and sedation [3] - Dosage Form: Injection [3] - Specifications: 200 mg/20 mL, 500 mg/50 mL, 1,000 mg/100 mL [3] - ANDA Number: 217945 [3] - Applicant: Nanjing Jianyou Biochemical Pharmaceutical Co., Ltd. [3]