South Korean contract drug manufacturer Samsung BioLogics said Thursday that it has obtained its first-ever manufacturing approval from Canada’s drug regulators for a biologic product produced at its first plant in Songdo, Incheon.
With the addition, the company has now earned 14 manufacturing approvals from the world’s top drug regulators -- the US Food and Drug Administration, the European Medicines Agency, Japan’s Pharmaceuticals and Medical Devices Agency and now Health Canada.
Eleven of the approvals are for products produced at the first plant, while the remaining three are for products manufactured at the second plant, the company said.
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(Samsung BioLogics) |
Contract drug manufacturing firms like Samsung BioLogics produce biologics based on orders placed by global drugmakers. And every product made by a CMO must be approved by the drug regulator of the country where the product is headed.
Samsung BioLogics said it now has the green light to produce products that can be sold in the US, Europe, Japan and Canada -- the world’s biggest markets for biologic drugs. Together, the US and Canada are said to make up 60 percent of this market.
“Being able to quickly obtain manufacturing approvals is pivotal for the biopharma industry where bringing a particular product to market faster than competitors is important,” Samsung BioLogics said in a statement.
“With a plant design maximizing efficiency and our accumulated expertise in quality assurance, we’ve greatly shortened our regulatory certification time. And with this, we are dedicated to helping our clients bring their products to market with speed and stability.”
By Sohn Ji-young (
jys@heraldcorp.com)
