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Contract manufacturers settle on unapproved drugs

This article was originally published in The Tan Sheet

Executive Summary

FDA bars two firms from producing and distributing unapproved, adulterated or misbranded nonprescription and Rx drugs, the agency says April 10. FDA said contract manufacturer Neilgen Pharmaceuticals, which does business as Unigen, and its parent company Advent Pharmaceuticals, each made and distributed 25 unapproved drug products, primarily prescription cough/cold products. In an April 10 release, FDA said the defendants, based in Westminster, Md., and East Windsor, N.J., will destroy their existing drugs and will not distribute new drugs without agency approval, according to a consent decree entered in federal court April 9. The firms also must retain outside experts to advise them on good manufacturing practices, the agency said





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