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Will Continuous Manufacturing Mean Continuous Generic Delay? FDA Hears AAM's Warning

 
• By Bowman Cox

Association for Accessible Medicines calls for US FDA to guard against use of continuous manufacturing methods to protect brand drugs from batch-manufactured generic drugs that may be of lower but still acceptable quality. Then FDA approves first generic of a continuously manufactured drug.

Batch versus continuous manufacturing
The future may be continuous -- and then back to batch

The organization that represents generic drug companies in the US has taken a hard line against technological innovation in pharmaceutical manufacturing that unfairly increases the quality of brand drugs.

The Association for Accessible Medicines Nov. 17 warned FDA to "remain vigilant" against brand firms' use of new technologies like continuous manufacturing to make drug products of such high quality...

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