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Hermes Pharma Completes First FDA Inspection

Wolfratshausen facility supports dosage forms for U.S. distribution

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Hermes Pharma has successfully completed its first FDA inspection of its production facility in Wolfratshausen, Germany. The inspection covered reviews of general systems, including training, equipment calibration and qualification, standard operating procedures, protocols and methods. It also appraised Hermes Pharma’s Hazard Analysis and Critical Control Point (HACCP) system.


The Wolfratshausen facility along with a production facility in Wolfsberg, Austria, allows Hermes to support global customers looking to license user-friendly dosage forms for distribution and sale in the U.S. The two plants are equipped with similar production lines to help ensure supply without interruptions. Dosage forms include instant drinks, orally disintegrating granules, lozenges, effervescent and chewable tablets.


“As a developer of pharmaceuticals and food supplements we work on a global basis, and understand and value compliance – to assure quality and adherence for our customers,” said Dr. Thomas Hein, director of sales and business development, Hermes Pharma. “This represents an important milestone for Hermes Pharma as the company steadily increases its manufacturing support for pharmaceutical companies around the world, especially those that seek access to the US marketplace or are already operating in the country.”

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