SiO2 Medical Products Receives Marketing Authorization for Filled 6mL Vials

SiO2 Medical Products, Inc. received marketing authorization (MA) for the Type II variation of the primary packaging of zoledronic acid from the German Medicines Authority BfArM on November 25, 2016. The drug, zoledronic acid, is packaged in a proprietary 6mL vial developed by SMP. The proprietary 6mL vial incorporates a silicon-based barrier coating system that combines the durability, pH stability, and dimensional consistency of an engineered polymer (such as a cyclic olefin polymer) with the barrier properties and low extractables of silica glass. This unique packaging solution may provide an ideal primary container for a myriad of pharmaceutical or biologic therapies – including zoledronic acid. The marketing authorization application was submitted on August 22, 2016 to the German authorities detailing a product filing for a Type II variation of an existing marketing authorization. Accompanying the submission was a 6-month formal stability study and leachable testing. SMP anticipates a similar approach for marketing authorization of other pharmaceutical or biologic therapies in its proprietary primary containers.