SunGen Pharma Establishes Injectable Division, Forms Manufacturing Relationship
SunGen Pharma recently announced it has entered into a Manufacturing Agreement with Grand River Aseptic Manufacturing (GRAM) to manufacture generic injectable pharmaceutical products.
“We are excited to work with GRAM on the manufacturing of these important injectable products, and are pleased to announce that we have successfully filed an injectable ANDA manufactured by GRAM. It is an antispasmodic and anticholinergic agent. We expect our next ANDA manufactured by GRAM to be filed with US FDA by the end of 2019. The product is used in combination chemotherapy,” said Dr. Isaac Liu, Co-CEO of SunGen Pharma, “SunGen continues to build a strong pipeline by combining our own products and those co-developed with partners around the world.”
SunGen Pharma launched its first injectable product in August 2017. The company expanded its injectable division in October 2017 through the acquisition of a privately held pharmaceutical company based in Monmouth Junction, NJ. It currently has more than 30 products in its pipeline, and it has more than 15 co-development, manufacturing, and marketing partners in North America, Europe, and Asia.
“The relationship between SunGen and GRAM has been very productive and the companies continue working on additional products for future filings. We are excited to support SunGen’s efforts to fill specific needs in the pharmaceutical marketplace,” said Thomas Ross, CEO of GRAM.
SunGen Pharma, LLC is a privately held specialty pharmaceutical company that 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 pharmaceutical products around the world.
Grand River Aseptic Manufacturing, Inc. (GRAM), a parenteral contract development and manufacturing organization, delivers customized solutions to meet clients’ fill and finish needs from development through commercialization. With capabilities for biologics as well as controlled substances, GRAM’s expert project managers and modern facilities support pharmaceutical development and cGMP manufacturing, analytical testing and regulatory filing.
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