Biomatrix Receives FDA Approval to Ship From New U.S. Facility
Biomatrix Inc. has received FDA approval to ship Synvisc that has been manufactured and packaged in its U.S. manufacturing plant located in Ridgefield, NJ. Synvisc is the company's treatment for osteoarthritis of the knee.
Biomatrix' new plant has already received ISO 9001/EN 46001 certification which allows for international shipments of CE marked devices manufactured in this facility. Biomatrix' Canadian manufacturing plant also has ISO 9001/EN 46001 certification, FDA, and Canadian regulatory approvals and is shipping product worldwide.
Biomatrix manufactures elastoviscous products made from proprietary biological polymers called hylans, used in therapeutic medical applications and in skin care products.
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