KUALA LUMPUR, Sept 6 (Bernama) -- SunGen Pharma, a privately held specialty pharmaceutical company has received its seventh ANDA approval from the United States (US) Food and Drug Administration (FDA).
The approved ANDA is for Fosapreptant for Injection 150mg/vial product which is used for treatment of cyclic vomiting syndrome and late-stage chemotherapy induced vomiting.
“Our high quality development expertise is further demonstrated by the short approval timeline. It takes US FDA less than 10 months to approve this important ANDA,” said the company’s co-founder and co-chief executive officer, Dr Isaac Liu.
SunGen established its injectable division in October 2017 through the acquisition of a privately held pharmaceutical company based in Monmouth Junction, New Jersey, according to a statement.
The company launched its first injectable product, Terbutaline Sulfate, as a prefilled liquid vial with a strength of 1mg/1ml. The product was launched on July 10, 2017.
In August last year, SunGen entered into a strategic manufacturing partnership with Grand River Aseptic Manufacturing to collaborate in the manufacturing and commercialisation of generic injectable pharmaceutical products.
In addition, in June this year, the company launched Bivalirudin through PIV Challenges in the US, in partnership with Athenex and Hainan Shuangcheng Pharmaceuticals.
-- BERNAMA
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