SiO2 Medical Products, Inc. Receives Marketing Authorization for Filled 6-mL Vials
SiO2 Medical Products, Inc. (SMP) 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 6-mL vial developed by SMP. The proprietary 6-mL 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.
For more information regarding the submission and SiO2 Medical Products, Inc.’s platform of products, please contact sio2-info@sio2med.com.
About SiO2 Medical Products, Inc.
SiO2 Medical Products, Inc. designs, develops, manufactures, and supplies precision-molded primary containers, labware, and consumable products molded from medical grade engineered polymers, such as cyclic olefin polymer. These unique products incorporate thin, transparent coatings or treatments on the drug contact surfaces to provide the best qualities of both standard plastic and glass containers, without their respective drawbacks. The company is headquartered in Auburn, Alabama, with sales, marketing, legal, and project management capabilities based out of offices near Philadelphia, PA.
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