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Grand River Aseptic Gains FDA Registration



Published September 13, 2011
Related Searches: Manufacturing Sterile cGMP Aseptic
Grand River Aseptic Manufacturing, Inc. is now FDA registered and will begin manufacture of cGMP product for its first commercial client. “This is a fabulous opportunity for our organization,” said Grand River’s president, Gregory Gonzales. “Obtaining a commercial product brings tremendous value to the selling cycle for continued growth.”

Grand River’s 11,400-sq.-ft facility has been fully validated and deemed ready for manufacture of injectable sterile products for clinical trials and commercial use. The company has a Class 100 aseptic filling suite along with lyophilization, analytical and microbiological services, and regulatory support. The facility has the capability to handle biotech, small molecule, biologic and protein pharmaceuticals.


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