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.

Related Contract Manufacturing:

  • CROs and Today’s  R&D Landscape

    CROs and Today’s R&D Landscape

    Kristin Brooks, Associate Editor, Contract Pharma||November 9, 2016
    John Lewis of ACRO discusses opportunities, challenges, and the future CRO

  • Choosing Oral Formulations for First-in-man Clinical Trials

    Choosing Oral Formulations for First-in-man Clinical Trials

    Jon Sutch, Senior Manager of Formulation Development, Patheon||October 11, 2016
    Early formulations should be simple, but selecting a simple formulation isn’t as easy as it seems

  • Robust Assay Designs

    Robust Assay Designs

    Tim Wright, Editor, Contract Pharma||October 11, 2016
    Easing the transition from preclinical to clinical research