BAUDETTE, Minn., Jan. 16, 2024 (GLOBE NEWSWIRE) --  ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that it received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Indomethacin Oral Suspension (OS), USP. ANI’s Indomethacin OS is the generic version of the Reference Listed Drug (RLD) Indocin® Oral Suspension.

明尼苏达州波德特，2024年1月16日（环球通讯社）--ANI制药公司（ANI或该公司）（纳斯达克：ANIP）今天宣布，它已获得美国食品和药物管理局（FDA）对USP吲哚美辛口服混悬液（OS）缩写新药申请（ANDA）的批准。ANI的吲哚美辛OS是参考药物（RLD）吲哚美辛®口服混悬液的通用版本。

The current annual U.S. market for Indomethacin OS is approximately $4.1 million, according to the latest estimates from IQVIA/IMS Health, a leading healthcare data and analytics provider. 'With this approval, the FDA has granted Indomethacin OS a Competitive Generic Therapy (CGT) designation, with 180-day exclusivity.

据领先的医疗保健数据和分析提供商IQVIA/IMS Health的最新估计，目前美国消炎痛OS的年度市场约为410万美元经批准，FDA授予吲哚美辛OS竞争性仿制药（CGT）称号，具有180天的独家经营权。

ANI continues to hold the second highest number of CGT approvals in the U.S. Generics market, highlighting the strong capabilities and execution of our Generics R&D team. We are happy to leverage the CGT pathway to provide our customers and patients in need with expanded access to high quality generics for limited competition products,” stated Nikhil Lalwani, President and Chief Executive Officer of ANI.         About ANIANI Pharmaceuticals, Inc.

ANI继续保持美国仿制药市场第二高的CGT批准数量，突出了我们仿制药研发团队的强大能力和执行力。ANI总裁兼首席执行官Nikhil Lalwani表示：“我们很高兴利用CGT途径，为有需要的客户和患者提供更多的机会，为有限竞争产品提供高质量的仿制药。”。关于ANIANI Pharmaceuticals，Inc。

(Nasdaq: ANIP) is a diversified biopharmaceutical company serving patients in need by developing, manufacturing, and marketing high quality branded and generic prescription pharmaceutical products, including for diseases with high unmet medical need. Our team is focused on delivering sustainable growth by scaling up our Rare Disease business through the successful launch of our lead asset, Purified Cortrophin® Gel, strengthening our generics business with enhanced research and development capability, innovation in established brands and leveraging our North American manufacturing capabilities.

（纳斯达克：ANIP）是一家多元化的生物制药公司，通过开发，制造和销售高质量的品牌和仿制药处方药产品，包括针对医疗需求未得到满足的疾病，为有需要的患者提供服务。我们的团队致力于通过成功推出我们的领先资产纯化的Cortrophin®凝胶来扩大我们的罕见病业务，通过增强研究和开发能力来加强我们的仿制药业务，创新知名品牌并利用我们的北美制造能力，从而实现可持续增长。

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