The company previously relied on Biofrontera Pharma as the primary supplier and manufacturer of its products. Following a Strategic Transaction, the company assumed full control of the Ameluz New Drug Application and Investigational New Drug, enabling it to take full responsibility for manufacturing Ameluz and RhodoLED Lamps in the United States. Temporarily, the company will continue to depend on Biofrontera Pharma for Ameluz manufacturing until all required licenses and contracts are finalized. The company has entered into an agreement with Midas Pharma GmbH in Germany for the primary procurement of the active pharmaceutical ingredient (API) and has identified a secondary API source with plans to establish a similar agreement. Ameluz production is conducted by contract manufacturers Glaropharm AG in Switzerland and Pharbil Waltrop GmbH in Germany, with Pharbil Waltrop GmbH recently qualified to support supply chain stability and manage tariff impacts. RhodoLED Lamp production is currently performed by Biofrontera Pharma in Leverkusen, Germany, with responsibility set to transfer to the company pursuant to the Strategic Transaction.
Biofrontera Inc's Comment on Supply Chain
The company previously relied on Biofrontera Pharma as the primary supplier and manufacturer of its products. Following a Strategic Transaction, the company assumed full control of the Ameluz New Drug Application and Investigational New Drug, enabling it to take full responsibility for manufacturing Ameluz and RhodoLED Lamps in the United States. Temporarily, the company will continue to depend on Biofrontera Pharma for Ameluz manufacturing until all required licenses and contracts are finalized. The company has entered into an agreement with Midas Pharma GmbH in Germany for the primary procurement of the active pharmaceutical ingredient (API) and has identified a secondary API source with plans to establish a similar agreement. Ameluz production is conducted by contract manufacturers Glaropharm AG in Switzerland and Pharbil Waltrop GmbH in Germany, with Pharbil Waltrop GmbH recently qualified to support supply chain stability and manage tariff impacts. RhodoLED Lamp production is currently performed by Biofrontera Pharma in Leverkusen, Germany, with responsibility set to transfer to the company pursuant to the Strategic Transaction.
Sources:
Biofrontera Inc 's official press releases and regulatory filings; CSIMarket.com's supply-chain research; and the financial filings and press releases of other companies cited in this report.
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