Adial Pharmaceuticals announced on June 25, 2025, the execution of agreements for the U.S.-based production of AD04 (0.33 mg ondansetron tablets). These agreements support the completion of upcoming clinical trials and the planned New Drug Application (NDA) submission to the FDA for Alcohol Use Disorder (AUD).
The company has partnered with Thermo Fisher Scientific as the Contract Development and Manufacturing Organization (CDMO) for AD04 Drug Product, and Cambrex as the drug substance CDMO and supplier of Ondansetron API. Demonstration batches have already been completed, marking initial progress in this collaboration.
These strategic agreements cover all phases of manufacturing, including clinical supplies for upcoming studies and the Chemistry, Manufacturing, and Controls (CMC) module documentation required for NDA submission. Securing these U.S.-based manufacturing capabilities is crucial for meeting timelines and eventual commercial demands, while also mitigating supply chain risks.
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