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Deficient DMFs Jeopardizing Timely Approvals of ANDAs

 
• By Joanne S. Eglovitch

The pressure is on for API makers to submit higher quality Type II drug master files, or DMFs. FDA official says many US ANDA approvals are delayed by poor quality DMFs. A representative of the generic drug industry, however, contends that FDA is partially to blame for this problem by setting impractical expectations and an unrealistically high bar for DMFs.

Active pharmaceutical ingredient manufacturers should improve the quality of their Type II drug master file (DMF) submissions to speed approvals of the DMFs and the generic drug applications that reference them, an FDA official said May 24 at the Association for Accessible Medicines’ Chemistry, Manufacturing and Controls Workshop in Bethesda, Md.

There is much room for improvement, according to Ramnarayan Randad, a chemist with the Office of Pharmaceutical Quality in FDA's Center for Drug Evaluation and Research: 98% of DMFs are...

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