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SunGen Pharma 制药获得美国 FDA 的第七个 ANDA 批准

SunGen Pharma 制药获得美国 FDA 的第七个 ANDA 批准

新泽西州普林斯顿市, Sept. 06, 2019 (GLOBE NEWSWIRE) — SunGen Pharma, 一家私人控股的研发,生产,和销售制剂产品的制药公司,今天宣布其已获得美国食品与药物管理局(FDA)的第七个 ANDA文号 批准。 第七个ANDA的产品名为注射液福沙匹坦 (Fosapreptant for Injection), 规格为150mg/vial。该药品是一種肿瘤辅助用药,用于肿瘤治疗过程中化疗的辅助用药,防止化疗引起的恶心、呕吐。据IMS显示,该产品为美国市场上的次级重磅产品,其市场规模在2018年超过了3.5亿美元。 原研药Emend®的橙皮书专利于9月4日到期,SunGen制药公司于9月5日就获得了其仿制药ANDA批准,成为这个巨大市场中所有仿制药获批的第一波。 “在原研药专利到期后第二天即获得其仿制药的第一波批准代表了我们团队所取得的另一个重要里程碑”,该公司联合创始人兼联合首席执行官刘洪斌博士说。“能够在最短时间内获得美国食品与药物管理局 FDA 批准进一步证明了我公司强大和高质量的开发能力。我们只用了不到10个月的时间就获得了这个重磅药证文号的美国FDA批准”。 2016年1月,SunGen Pharma 在美国新泽西创立了口服和乳膏软膏的研发中心。 2016年8月, SunGen Pharma与美国上市公司Elite Pharmaceuticals, Inc. 签订开发和许可协议, 合作开发四种仿制药产品并实现商业化。 2016年9月,SunGen Pharma与美国上市公司Athenex Pharmaceuticals成立销售和营销合资企业Peterson Athenex Pharmaceuticals, 共同研发和销售七种医药产品。 2017年10月,SunGen Pharma收购了位于美国新泽西州蒙茅斯枢纽的一家私营制药公司, 成立了无菌注射剂团队。该公司推出了其首款注射产品特布他林(Terbutaline Sulfate Injection, USP ), 规格为1mg/1ml, 1mL西林瓶。该产品于2017年7月10日实现商业化并上市到美国市场。 2018年8月, SunGen Pharma宣布与美国Grand River Aseptic Manufacturing无菌生产工厂建立战略制造合作伙伴关系, 合作生产无菌注射剂药品并实现商业化。 2018年10月,SunGen Pharma及其合作伙伴从瑞士山德士Sandoz购买了抗癌药白消安注射液(Busulfan injection) ANDA, 并在 2019 年 […]

SunGen Pharma Receives Seventh ANDA Approval from US FDA

SunGen Pharma Receives Seventh ANDA Approval from US FDA

PRINCETON, N.J., Sept. 05, 2019 (GLOBE NEWSWIRE) — SunGen Pharma, a privately held specialty pharmaceutical company which develops, contract manufactures, and sells pharmaceutical finished products, today announced it has received its seventh ANDA approval from the US Food and Drug Administration (FDA). The seventh approved ANDA is for Fosapreptant for Injection 150mg/vial. This drug product is used for treatment of […]

American Land Title Association Statement on Trump Administration’s Plans for Housing Finance Reform

Washington, D.C., Sept. 05, 2019 (GLOBE NEWSWIRE) — The American Land Title Association (ALTA), the national trade association of the land title insurance industry, issued the following statement in response a proposal released by the U.S. Department of the Treasury to reform the housing finance system. The plan is in response to a presidential memorandum the Trump Administration issued in […]

North America 3D Printing Equipment and Material Market to accrue over 35% share in 2024: Global Market Insights, Inc.

North America 3D Printing Equipment and Material Market to accrue over 35% share in 2024: Global Market Insights, Inc.

Selbyville, Delaware, Sept. 06, 2019 (GLOBE NEWSWIRE) — Global Market Insights, Inc., announces a report on ‘3D Printing Materials & Equipment Market Trends & Forecast to 2024’. The study provides information about the product, end-user, and regional landscapes of this industry. will be driven by robust growth in aerospace and defense industries. This growth can be attributed to reduced air […]

Myovant Sciences’ Founding Shareholder Roivant Sciences, and Sumitomo Dainippon Pharma Enter into a Memorandum of Understanding to Create a Broad Strategic Alliance

Myovant Sciences’ Founding Shareholder Roivant Sciences, and Sumitomo Dainippon Pharma Enter into a Memorandum of Understanding to Create a Broad Strategic Alliance

BRISBANE, Calif. and BASEL, Switzerland, Sept. 06, 2019 (GLOBE NEWSWIRE) — Myovant Sciences (NYSE: MYOV) today announced that its founding shareholder, Roivant Sciences, and Sumitomo Dainippon Pharma Co., Ltd. (TSE: 4506) (“Sumitomo Dainippon”), a leading global Japanese pharmaceutical company, have announced their entry into a for the creation of a broad strategic alliance. The Sumitomo Dainippon-Roivant Alliance (“Alliance”) is expected to create a new […]