The USFDA has approved Amarin supplemental new drug application for Chemport as additional Vascepa active pharmaceutical ingredient supplier.
The approval adds to the company's planned expansion of the Vascepa manufacturing supply chain and expansion of patent protection for Vascepa in the US.
Amarin chairman and chief executive officer Joseph Zakrzewski said the sNDA approval of Chemport expands the company's global supply chain to reach expected Vascepa demand, diversify supply base, and ensure cost-efficient supply.
"The addition of Chemport as an approved API supplier supplements Amarin's current proven API supply source, Nisshin Pharma, Inc.," Zakrzewski added.
Source:
http://regulatoryaffairs.pharmaceutical-business-review.com/news/fda-approves-chemport-as-additional-vascepa-active-pharmaceutical-ingredient-supplier-190413
