Biofrontera Receives FDA approval for Upscaling of Batch Size for Ameluz Production

Biofrontera announced the U.S. Food and Drug Administration (FDA), and earlier the European Medicines Agency (EMA), have approved the upscaling of the batch size for the production of Ameluz to 35 kg from previously 7 kg.

"The approval for a 5-fold increase in batch size ensures a secure supply of Ameluz to meet the growing demand for Ameluz in all regions. Scaling the manufacturing process by significantly increasing the batch size also allows for a substantial improvement of our gross margin," Prof. Dr. Hermann Lübbert, CEO of Biofrontera said. "We have reached another milestone of operational success, which answers to the overall success story of Ameluz."

The FDA-approval is effective January 3, 2019. The FDA defines a batch as a specific quantity of a drug that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing process in the same cycle of manufacture.

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