The Germantown, WI facility of Cambridge Major Laboratories (CML) has undergone its first FDA inspection and commercial launch of an API. The company’s manufacturing facilities were the subject of a FDA inspection, which included a pre-approval inspection (PAI) and a general quality systems inspection of both sites.
The FDA inspection represents the first for CML's newest, large-scale API manufacturing facility and the company's seventh inspection in the past nine years. CML currently manufactures more than a dozen commercial products including innovative new drugs, generic substances, and medical imaging agents.
“The inspection and subsequent commercial launch is a major milestone for CML, which is the first for our new, state-of-the-art, large-scale API facility,” said Brian Scanlan, CML's president and chief executive officer. “Our objective, as always, is to ensure that our systems are in compliance with FDA requirements. I am very pleased with the outcome of the inspection which demonstrates the full devotion of the management and employees.”
Within two months of the successful PAI, the FDA announced approval of the product, which represents the first commercial product produced in CML's new facility. “The NDA approval is a significant milestone for our newest facility and a clear sign that we are open for business at the facility,” said Mr. Scanlan.