Grünenthal Pharma produces for Biofrontera
Biofrontera AG and Grünenthal Pharma AG will in the future cooperate on product manufacturing. The companies Biofrontera Pharma GmbH and Grünenthal Pharma AG have signed an agreement for the production of Biofrontera's products BF-200 ALA and Reliéva. BF-200 ALA is a dermatological drug for the treatment of actinic keratosis, Reliéva a medicinal skin care product line for nourishing skin with dandruff, dermatitis, or itching.
The Grünenthal Pharma AG obtains rights for the European production of both products for 7 years following market introduction. In return Grünenthal covers all costs for the development of the entire production process, the manufacturing of the stability batches and the analytical tests.
Pharmaceutical products such as BF-200 ALA and Reliéva must be produced under GMP conditions, requiring detailed documentation of the manufacturing processes. Such products can only be launched if they have excellent and fully documented quality and purity. Moreover, the manufacturer has to guarantee the stability and reproducibility of the entire production process.
Reliéva will be introduced into the market within only few months. BF-200 ALA is currently tested in the final pivotal phase III clinical trial. In a first, completed phase III trial, BF-200 ALA has already demonstrated excellent efficacy. Based on the high innovation potential of BF-200 ALA the European authority EMEA has agreed to a centralized registration procedure.
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