API Maker Cambridge Launches New Manufacturing Facility

Cambridge Major Laboratories (CML) has announced the first FDA inspection and commercial launch of an API of the Company’s newest facility.

The Germantown, Wisconsin 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