SunGen Pharma Receives Its Second & Third ANDA Approval from US FDA

SunGen Pharma recently announced it has received its second and third ANDA approval from the US FDA. The second ANDA is Amphetamine Salts, a generic version of Adderall, an immediate-release tablet used to treat Narcolepsy and Attention Deficit Hyperactivity Disorder (ADHD). Amphetamine Salts had total US sales of $364 million for the 12 months ending September 30, 2018 according to IQVIA.

The third ANDA is a generic version of Deltasone, an immediate-release Prednisone product with various strengths 2.5 mg, 5 mg. 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 US sales of $121 million for the 12 months ending September 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 second and third product approval for SunGen in 2018. The total number of ANDA filed by SunGen to US FDA in 2018 will be 11.”

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, NJ. The company launched its first injectable product Terbutaline Sulfate as a prefilled liquid vial with a strength of 1 mg/1 ml. 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 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. For more information, visit