Chemwerth Inc

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Description

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.

In 1998, ChemWerth established a laboratory as part of our Shanghai operations to provide analytical support for our partner manufacturers and customers. Using modern, state-of-the-art equipment and software, and operated by a highly skilled, bi-lingual and knowledgeable staff, our lab provides analytical services in the areas of method development, method validation, and routine analysis of drug substances, including key raw materials and intermediates.

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.

ChemWerth is committed to be the USA’s leading supplier of reliable, high-quality APIs to finished dosage pharmaceutical manufacturers at competitive prices and enhanced by our superior technical and regulatory support services. According to Mr. Peter Werth, CEO of ChemWerth, “Today’s challenges in the API manufacture and supply industry demand new perspectives and initiatives. Credit ChemWerth was established to keep pace with the growing competition and trend toward supply chain globalization.

Our regulatory department continues to expand in both the US office and the Shanghai office. Our goal remains the same, to provide technical and regulatory expertise to our contract manufacturers and to provide the technical and regulatory support to our customers that help them get the speedy approval needed to maintain a competitive advantage.

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