Core Viewpoint - Amneal Pharmaceuticals has received FDA approval for prednisolone acetate ophthalmic suspension, a significant addition to its Affordable Medicines portfolio, with a planned launch in Q3 2025 [1][3]. Group 1: Product Details - Prednisolone acetate ophthalmic suspension, USP 1%, is a sterile topical anti-inflammatory agent indicated for treating steroid-responsive ocular inflammation [2]. - The product is a complex formulation that demonstrates the company's R&D capabilities and manufacturing strength [3]. Group 2: Market Insights - According to IQVIA, the U.S. annual sales for prednisolone acetate ophthalmic suspension were approximately $201 million for the 12 months ending April 2025 [4]. Group 3: Company Overview - Amneal Pharmaceuticals, Inc. is a global biopharmaceutical company based in Bridgewater, NJ, with a diverse portfolio of over 280 pharmaceuticals, primarily in the U.S. market [5]. - The company is expanding its Affordable Medicines segment across various complex product categories, including injectables and biosimilars [5].

Group 1 - The company, Shapuaisi (603168), has received the approval notice for the supplementary application of Levofloxacin Eye Drops from the National Medical Products Administration [1] - The drug is indicated for bacterial infections including Staphylococcus and Streptococcus, with applications for conditions such as blepharitis and conjunctivitis [1] - The company has invested approximately 5.93 million yuan in the research and development of this product, which is expected to enhance its market competitiveness [1]