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news.Galmed Pharmaceuticals has entered into a manufacturing services agreement with Perrigo API for the large-scale production of the active pharmaceutical ingredient (API) of Galmed's product candidate, aramchol.
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The API produced is expected to provide sufficient quantities of aramchol for Galmed’s potential future Phase III clinical trials of aramchol to treat Non-Alcoholic Steato-Hepatitis (NASH).
As part of the deal, Perrigo will offer manufacturing process optimization services for large-scale production of the aramchol API and manufacture the aramchol API pursuant to current good manufacturing processes (cGMP)
The company will carry out additional development services regarding scale-up and manufacturing optimization for the aramchol API.
The deal also provides Perrigo with the option to manufacture commercial supplies of the aramchol API in the future.
Galmed chief executive officer Allen Baharaff said: "We believe that initiating the process of large-scale API production now may facilitate the commencement of our potential future Phase III clinical trials, assuming applicable regulatory approval to conduct the same, and provide preferential pricing, which we believe may ultimately provide a more affordable treatment option for NASH patients in the future."
Perrigo is focused in developing, manufacturing and distributing over-the-counter (OTC) and generic prescription pharmaceuticals, nutritional products and APIs.