2013 FDA Approval
After an extensive on-site review, the FDA has determined that GRAM meets all requirements for production of parenteral drug products, both aseptically filled and terminally sterilized.
The Latest From Grand River Aseptic Manufacturing
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Inside GRAM’s New Groninger Syringe & Cartridge Filling Line: What Modern Fill-Finish Technology Means for Biologic Drug Manufacturers
As biologic therapies continue to reshape pharmaceutical development, the demands placed on sterile fill-finish manufacturing have never been higher. Pharmaceutical...
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Annex 1 is Not the Ceiling for Compliance; It is the Foundation
The sterile manufacturing industry is undergoing a significant transformation as regulatory agencies shift towards a comprehensive approach to compliance. GRAM...
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Grand River Aseptic Manufacturing Announces $100 Million Investment in Sterile Manufacturing Capabilities
The company is enhancing its U.S. sterile fill-finish contract manufacturing services to meet growing industry demand for prefilled syringes and...