PRINCETON, N.J., Jul. 8 (Korea Bizwire) — SunGen Pharma, a privately held specialty pharmaceutical company which develops, contract manufactures, and sells pharmaceutical finished products, today announced it has received its sixth ANDA approval from the US Food and Drug Administration (FDA).
The sixth approved ANDA is for Methylprednisolone tablets, 4 mg. This drug product is a corticosteroid used to treat conditions including arthritis, allergic reactions, and immune system disorders, as well as dermatologic, ophthalmic, respiratory, and gastrointestinal diseases. Methylprednisolone tablets had total U.S. sales of $93 million for Q1 of 2019, and $113 million and $124 million, respectively, for 2018 and 2017 according to IQVIA.
“These approvals represent one 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 sixth approval for SunGen. Our strong development capabilities are further supported by the short timeline in which US FDA has approved our dossiers.”
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 announced launch of Bivalirudin through PIV Challenges in US, in partnership with Athenex and Hainan Shuangcheng Pharmaceuticals.
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.
SunGen Pharma LLC
Source: SunGen Pharma LLC via GLOBE NEWSWIRE