ScinoPharm, a leading 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.
Viibryd is a novel drug for the treatment of adults with major depressive disorder (MDD). The drug's dual mechanism of action and side effect profile differentiates itself from other antidepressants. Use of Viibryd did not cause significant weight gain or interference with sexual function as seen with some rival drugs.
"ScinoPharm is proud of the fruitful partnership with Clinical Data by being its sole API supplier of vilazodone hydrochloride during Viibryd's launch. Beginning from process research through timely development and optimization of long and complicated synthetic processes, we have established a win-win partnership," said Dr. Jo Shen, President and CEO of ScinoPharm.
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.
Adeno-associated virus: The gene therapy revolution faces manufacturing and safety hurdles