Lantheus gets FDA approval for drug manufacturing facility in Billerica
Lantheus Holdings has secured approval from the US Food and Drug Administration (FDA) for the supplemental drug application (sNDA) for its isolator-based drug manufacturing facility for DEFINITY (Perflutren Lipid Microsphere) in North Billerica, Massachusetts.
According to the US-based provider of diagnostic imaging agents, DEFINITY is an ultrasound enhancing agent in the US for patients having suboptimal echocardiograms.
Lantheus had built the specialized, in-house manufacturing facility at its headquarters in North Billerica for producing DEFINITY and possibly other sterile vial products.
The 16,000sft isolator-based drug manufacturing facility can meet Lantheus’ current demand for DEFINITY, while offering flexibility for potential growth opportunities in the future.
Mary Anne Heino — President and CEO of Lantheus said: “Achieving approval of our on-site manufacturing facility was a Company-wide effort and represents an important step forward for Lantheus’ strategy to improve the security of DEFINITY supply.
“This facility will provide the Company with supply chain redundancy and the opportunity for margin expansion as we progressively include DEFINITY inventory from this facility into our supply chain. We intend to begin shipping DEFINITY from our on-site manufacturing facility to customers immediately.”