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Cambridge Major Sites Inspected, Launches API

Pre-Approval Inspection leads to commercial API launch

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By: Tim Wright

Editor-in-Chief, Contract Pharma

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 curre...

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