Daiichi Sankyo has received FDA approval to package product at its first U.S.-based packaging facility, located in Bethlehem, PA. The approval expands DS' global supply chain capability.
The 140,000-sq.-ft. facility will package some of the company's portfolio of marketed products for cardiovascular and metabolic therapies, including treatments for hypertension and heart disease, diabetes and hyperlipidemia. In future, the facility could assume additional responsibilities related to clinical trial materials and perform formulation and analytical testing for select products.
"From facility and process design to quality control and personnel flow, we incorporated leading-edge technology in the design and development of the Bethlehem facility," said Jeff Lane, vice president, Operations, Daiichi Sankyo, Inc. "The commissioning of this facility is a major milestone for our U.S. organization and augments our ability to manufacture and distribute quality medicines."
The plant currently employs approximately 39 full-time employees and will continue to add employees until reaching its full operational goals. Mr. Lane noted that by expanding the company's business operations to include manufacturing in the U.S., DS is helping to minimize risks associated with product supply, and is able to gain greater control over the lifecycle of its products, from research and development through packaging and distribution.