Hermes Pharma Completes FDA Inspection

July 1, 2013

Hermes Pharma announced that the company completed a successful inspection by the US FDA of its production facility located in Wolfratshausen, Germany.

Hermes Pharma, a division of Hermes Arzneimittel GmbH, announced that the company completed a successful inspection by the US Food & Drug Administration (FDA) of its production facility located in Wolfratshausen, Germany. Hermes Pharma is a manufacturer of food supplement products to the US; the inspection marks the first routine inspection of a Hermes Pharma facility by the FDA.

The Wolfratshausen facility, coupled with a production facility in Wolfsberg, Austria, enables Hermes Pharma to support global customers looking to license in user-friendly dosage forms for distribution and sale in the US. The two plants are equipped with similar production lines. User-friendly dosage forms such as instant drinks, orally disintegrating granules, lozenges, effervescent and chewable tablets represent a rapidly growing opportunity in the food supplement market, especially for patients who find swallowing pills difficult. The dosage forms are also gaining significant traction in the pharmaceutical sector as companies seek to better meet the needs of patients, while diversifying their product portfolio, strengthening their brands and extending product lifecycles, Hermes Pharma reports in a press statement.

The inspection covered reviews of general systems, including training, equipment calibration and qualification, standard operating procedures, protocols and methods. More than 800 million effervescent and chewable tablets are manufactured annually in Hermes Pharma’s production plant in Wolfratshausen. Opened in 1994, the plant is optimized for the manufacture of moisture-sensitive effervescent tablets as well as chewable tablets. Weighing, granulating, mixing, tableting and packaging take place in automated, closed systems spreading across 12,400 square-meters.