KUALA LUMPUR, July 9 (Bernama) -- SunGen Pharma, a privately held specialty pharmaceutical company has received its sixth ANDA approval from the United States (US) Food and Drug Administration (FDA).
The approval for Methylprednisolone tablets, 4 mg, is a corticosteroid used to treat conditions including arthritis, allergic reactions and immune system disorders, as well as dermatologic, ophthalmic, respiratory, and gastrointestinal diseases, according to a statement.
“This is the sixth approval for SunGen. Our strong development capabilities are further supported by the short timeline in which the US FDA has approved our dossiers,” said co-founder and co-chief executive officer, Dr Isaac Liu.
SunGen Pharma has started its oral and topical research and development centre in January 2016 and entered into a Development and License Agreement with Elite Pharmaceuticals Inc in August 2016, to collaborate, develop and commercialise four generic pharmaceutical products.
In June this year, the company announced the launch of Bivalirudin through PIV Challenges in the US, in partnership with Athenex and Hainan Shuangcheng Pharmaceuticals.
-- BERNAMA
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