Issue: Exclusive Online Content, Posted Date: 2/3/2017
SiO2 Medical Products, Inc. Receives Marketing Authorization for Filled 6-mL Vials
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.
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.
information regarding the submission and SiO2 Medical Products,
Inc.’s platform of products, please contact firstname.lastname@example.org.
About SiO2 Medical Products, Inc.
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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