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Shengnuo FDA Inspection

Woodbridge, CT/Shanghai, China — ChemWerth Inc. is pleased to announce that Chengdu Shengnuo Bio-Pharmaceutical Co., Ltd. (Shengnuo) new facility has passed FDA overseas inspection with zero 483 being issued in May 2012.  ChemWerth is the exclusive regulatory and sales agent for Shengnuo.

Shengnuo, founded in 2004, commissioned a state-of-the-art facility in 2011 for commercial manufacturing of cGMP quality peptides.  In 2006, the peptide factory at Dayi Industrial Park, an 18-acre campus, was completed.  It consists of three areas for production – a peptide synthesis pilot facility, a custom peptide R&D center and a generic API workshop.  Shengnuo has worked with the University of California Department of Chemistry to develop its R&D group to meet international standards of peptide synthesis and research.  Shengnuo’s main areas of focus are the production of peptide active pharmaceutical ingredients (APIs) and production of lyophilized powders for injection dosage formulation products.  Shengnuo has also successfully passed SFDA inspections in 2008, 2009 and 2010 for two peptide APIs and for the lyophilized powder for injection dosage formulation products.

ChemWerth and Shengnuo are collaborating to develop 10 peptide based APIs for the U.S. and other regulated markets overseas.  Bivalirudin was the first product submitted to FDA.  Director Wen Yongjun of Shengnuo stated, “Besides the Bivalirudin API, which was included in the inspection, we have a number of large volume peptides in development.  We completed the development of eptifibatide and are developing exenatide.”  ChemWerth and Shengnuo plan to have 10 new products developed by the end of 2013.  Shengnuo continues to be the primary supplier of peptide intermediates and high quality APIs to the Indian, European, Chinese and U.S. markets.

ChemWerth is committed to providing its customers with high quality products and ensuring that the manufacturing companies it represents and works with are cGMP compliant with FDA regulations.  According to Mr. Peter Werth, CEO of ChemWerth, “ChemWerth has worked with FDA in China for 30 years and has participated in more than 150 FDA inspections.  Our regulatory expertise in helping manufacturers like Shengnuo get FDA approved is a real value-added benefit for our customers.  We are proud to have Shengnuo as a manufacturing partner.”