Amarin Corp (AMRN) Submits sNDA for New Vascepa API Supplier
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Amarin Corp Plc (NASDAQ: AMRN) has submitted a Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval for Chemport, Inc. as an additional Vascepa® (icosapent ethyl) active pharmaceutical ingredient (API) supplier.
"A key goal of Amarin is to expand our global supply chain to support expected Vascepa demand, diversify our supply base and ensure cost-efficient supply," stated Joseph Zakrzewski, Chairman and Chief Executive Officer of Amarin. "The sNDA submission for Chemport is an important step toward achieving this goal."
This submission contributes to the planned expansion of the Vascepa manufacturing supply chain and is additional progress toward Amarin's goal to protect the commercial potential of Vascepa to beyond 2030 through a combination of patent protection, regulatory exclusivity, trade secrets and by taking advantage of manufacturing barriers to entry. Along with this expansion in supply, Amarin's significant progress includes expansion of patent protection for Vascepa in the United States with 11 Amarin patents either issued or allowed and over 30 additional patent applications being prosecuted. Amarin is also pursuing patent applications related to Vascepa in multiple jurisdictions outside the United States.
"A key goal of Amarin is to expand our global supply chain to support expected Vascepa demand, diversify our supply base and ensure cost-efficient supply," stated Joseph Zakrzewski, Chairman and Chief Executive Officer of Amarin. "The sNDA submission for Chemport is an important step toward achieving this goal."
This submission contributes to the planned expansion of the Vascepa manufacturing supply chain and is additional progress toward Amarin's goal to protect the commercial potential of Vascepa to beyond 2030 through a combination of patent protection, regulatory exclusivity, trade secrets and by taking advantage of manufacturing barriers to entry. Along with this expansion in supply, Amarin's significant progress includes expansion of patent protection for Vascepa in the United States with 11 Amarin patents either issued or allowed and over 30 additional patent applications being prosecuted. Amarin is also pursuing patent applications related to Vascepa in multiple jurisdictions outside the United States.
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