BFRI - Biofrontera Pharma lab in Germany gets FDA nod for testing skin disease therapy Ameluz

Biofrontera (NASDAQ:BFRI) said the U.S. Food and Drug Administration (FDA) approved Biofrontera Pharma’s cGMP laboratory in Leverkusen, Germany as a contract laboratory for batch control and stability testing of Ameluz. Ameluz (aminolevulinic acid hydrochloride gel, 10%) is used to treat actinic keratoses, skin growths caused by exposure to sunlight, which could lead to skin cancer. The company said the FDA cleared Biofrontera Pharma's laboratory to operate a method of impurity testing, which is a critical component of the gel’s stability assurance. The clearance enables part of the necessary testing of production batches to be performed in the Leverkusen facility, thus reducing dependence on third-party suppliers and the risk of production downtime and product delays. The company noted that previously, quality control was conducted by contract manufacturers in collaboration with third-party providers.

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Biofrontera Pharma lab in Germany gets FDA nod for testing skin disease therapy Ameluz