PRINCETON, N.J., April 29, 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 fourth and fifth ANDA approvals from the US Food and Drug Administration (FDA).
The fourth approved ANDA is a generic version of Deltasone®, an immediate-release Prednisone product with strength at 1mg. Various strengths at 10 mg, 20 mg, and 50 mg tablets have been approved previously during Aug 2018. Prednisone is used to treat conditions such as arthritis, blood disorders, breathing problems, severe allergies, skin diseases, cancer, eye problems, and immune system disorders. Prednisone belongs to a class of drugs known as corticosteroids. Prednisone Tablets had total U.S. sales of $121 million for the twelve months ending September 30, 2018 according to IQVIA.
The fifth approved ANDA is a generic version of Bentyl®, Dicyclomine Hydrochloride Injection USP, 20 mg/2 mL (10 mg/mL). It is a sterile injectable solution in 2mL-vial in cartons of 5. Dicylomine is used to treat a certain type of intestinal problem called irritable bowel syndrome. It helps to reduce the symptoms of stomach and intestinal cramping. Dicyclomine injection had total U.S. sales of $17 million for the twelve months ending December 30, 2018 according to IQVIA.
“These approvals represent two of many products being developed or co-developed by our company and with our partners around the world,” said Dr. Isaac Liu, Co-Founder and Co-CEO of the company. “This is the fourth and fifth product approvals for SunGen in 2019. Our strong development capabilities are further supported by the short time line in which US FDA has approved our dossiers: 9 months for Prednisone and 10 months for Dicyclomine.”
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 Pharmaceutical 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 10, 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.
About SunGen Pharma LLC
SunGen Pharma, LLC is a privately held specialty pharmaceutical company which develops, contract manufactures, and sells pharmaceutical finished products. SunGen specializes in the development of oral solid extended release, topical and complex injectable products. SunGen 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.
Contact:
SunGen Pharma LLC
Diana Chan
Office: (609) 606-1070
diana.chan@sungenpharm.com