US-based specialty pharmaceutical company SunGen Pharma announced that the US Food and Drug Administration (FDA) has granted Abbreviated New Drug Application (ANDA) for its Fosapreptant injection 150mg/vial.
SunGen said that the decision marks the seventh ANDA approval and its drug product is used for treating cyclic vomiting syndrome and late-stage chemotherapy induced vomiting.
SunGen co-founder and co-CEO Isaac Liu said: “This first wave generic approval right after RLD patent expiration represents another key milestone by our own team. 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 collaborates with generic pharmaceutical companies across the world
SunGen Pharma is engaged in the development of oral solid extended release, topical and complex injectable products has started its oral and topical research and development centre in January 2016.
The company has partnered with Elite Pharmaceuticals to develop and commercialise four generic pharmaceutical products, by signing a development and license agreement in August 2016.
In addition, it has established a sales and marketing joint venture with Athenex Pharmaceuticals in dubbed Peterson Athenex Pharmaceuticals to market seven pharmaceutical products.
In October 2017, SunGen has opened its injectable division through the acquisition of a New Jersey–based pharmaceutical company and launched its first injectable product Terbutaline Sulfate, as a prefilled 1mg/1ml liquid vial.
In 2018, the firm has signed a strategic manufacturing partnership with Grand River Aseptic Manufacturing to manufacture and commercialize generic injectable pharmaceutical products.
Furthermore, the company, along with its partners, has acquired Busulfan injectable ANDA from Sandoz and launched the product into US hospitals. It has also announced the launch of Bivalirudin in US, in partnership with Athenex and Hainan Shuangcheng Pharmaceuticals.
SunGen claims that it has business partnerships with many North American, European and Asian-based generic pharmaceutical companies to develop, manufacture, and sell several pharmaceutical products around the world.
