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Frontage Labs Achieves CMC Milestone

FDA completes review with no 483 citations

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Frontage Laboratories, Inc. has met FDA standards for testing commercial products in its Chemistry, Manufacturing and Controls (CMC) labs for the fourth time in four years. The FDA completed the annual review of CMC Quality and Lab Systems with no Form 483 citations. As a result, the Exton, PA, facilities maintain certification as commercial testing labs.

“We make it a priority to build in quality from start to finish for every project,” said Song Li, Ph.D., Frontage’s founder and chief executive officer. “This compliance certification from FDA is continued proof that our quality systems are working and it gives added confidence to our current and new clients.”

The Frontage CMC division provides pharmaceutical API development and GMP manufacturing, analytical testing, formulation product development and manufacturing of clinical trial materials including sterile, oral solid, topical, and high potent products.

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