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news.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).
Image: The US FDA’s Center for Drug Evaluation and Research. Photo: courtesy of The U.S. Food and Drug Administration/Wikipedia.org.
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The seventh approved ANDA is for Fosapreptant for Injection 150mg/vial. This drug product is used for treatment of cyclic vomiting syndrome and late-stage chemotherapy induced vomiting. This is a sub blockbuster product of over $350M US market size for 2018 according to IQVIA. RLD Emend’s orange book patent expired on Sep 4th and SunGen obtained its ANDA approval on Sep 5th, which makes it is the first wave of all generic approvals for RLD Emend.
“This first wave generic approval right after RLD patent expiration represents another key milestone by our own team” said Dr. Isaac Liu, Co-Founder and Co-CEO of the company. “Our high quality development expertise are further demonstrated by the short approval timeline. It takes US FDA less than 10 months to approve this important ANDA.”
SunGen Pharma started its oral and topical research and development center in January 2016.
In August 2016, it entered into a Development and License Agreement with Elite Pharmaceuticals, Inc. to collaborate to develop and commercialize four generic pharmaceutical products.
SunGen formed a sales and marketing joint venture with Athenex Pharmaceuticals in September 2016 named Peterson Athenex Pharmaceuticals to market seven pharmaceutical products.
SunGen established its injectable division in October 2017 through the acquisition of a privately held pharmaceutical company based in Monmouth Junction, New Jersey. The company launched its first injectable product, Terbutaline Sulfate, as a prefilled liquid vial with a strength of 1mg/1ml. The product was launched July 10th, 2017.
In August 2018, SunGen announced it has entered into a strategic manufacturing partnership with Grand River Aseptic Manufacturing to collaborate in the manufacturing and commercialization of generic injectable pharmaceutical products.
SunGen and its partners acquired Busulfan injectable ANDA from Sandoz in October 2018 and launched the product into US hospitals in March 2019.
In June 2019, SunGen Pharma announces to launch Bivalirudin through PIV Challenges in US, in partnership with Athenex and Hainan Shuangcheng Pharmaceuticals.
Source: Company Press Release
