Taiwan — ScinoPharm, an active pharmaceutical ingredient (API) and contract research and manufacturing (CRAM) service provider to the global pharmaceutical and biotechnology industry, will provide commercial manufacturing service of vilazodone hydrochloride active pharmaceutical ingredient (API) for Clinical Data, Inc.'s Viibryd, a new drug entity recently approved by the United States Food and Drug Administration.
The FDA's approval of Vibryd was recently covered in a Behavioral Healthcare online exclusive titled Viibryd: What Clinical Data can't say—at least not yet.
According to Clinical Data, Viibryd is a novel drug for the treatment of adults with major depressive disorder (MDD) and the drug's dual mechanism of action and side effect profile differentiates itself from other antidepressants.
"ScinoPharm is proud of the fruitful partnership with Clinical Data by being its sole API supplier of vilazodone hydrochloride during Viibryd's launch," said ScinoPharm president and CEO Dr. Jo Shen. "Beginning from process research through timely development and optimization of long and complicated synthetic processes, we have established a win-win partnership."
In relationship similar to the one with Clinical Data, ScinoPharm partners with other leading pharmaceutical companies for custom contract services from clinical materials to commercial. So far the company has handled more than 60 NCE projects, with 4 currently in phase III and 3 having already been approved for launch.
ScinoPharm is set to expand its CRAM services through its new GMP plant in Changshu, China, which is expected to be operational in Q3 2011. The Changshu plant will expand the company's overall R&D and production capabilities to capture the business opportunities in the rapidly expanding Asian pharmaceutical market.
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