Breaking News

Grand River Aseptic Gains FDA Registration

September 13, 2011

Facility is fully validated for manufacture of injectable sterile products

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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