This is the first commercial launch of an active pharmaceutical ingredient from its newest facility
Cambridge Major Laboratories (CML) has achieved the first commercial launch of an active pharmaceutical ingredient (API) from its newest facility in Germantown, Wisconsin, following a successful FDA inspection.
With facilities in the US and the Netherlands, the chemistry outsourcing company produces pharmaceutical intermediates and APIs from early preclinical development to commercial manufacture.
CML\'s two manufacturing facilities were the subject of a FDA inspection, which included a pre-approval inspection and a general quality systems inspection. This was the first for Cambridge Major\'s newest, large scale API manufacturing facility and the seventh inspection over the past nine years.
Within two months of the successful FDA pre-approval inspection, the FDA announced approval of the product which represents the first commercial product produced in Cambridge Major\'s new large scale facility. The approval adds to Cambridge Major\'s momentum as the company continues to add employees and services.
‘The NDA approval is a significant milestone for our newest facility and a clear sign that we are open for business at the facility. This particular CML facility is truly state-of-the-art and affords CML the capacity for growth and to continue serving customers with the highest level of service,’ said Brian Scanlan, president and ceo of CML.