Woodbridge, CT/Shanghai, China — ChemWerth Inc. (“ChemWerth”) is pleased to announce that Sichuan Credit-ChemWerth Pharmaceutical Co., Ltd. (“Credit-ChemWerth”) has passed FDA overseas inspection with zero 483 being issued in June 2012.
Established in July 2007, Credit-ChemWerth is a joint venture API manufacturer between ChemWerth, a full service generic active pharmaceutical ingredient (“API”) development and supply company, and Sichuan Credit Pharmaceutical Co. Ltd., a famous Chinese manufacturer of finish dosage form and API with strong R&D capabilities. The company focuses on R&D and manufacturing of chemical APIs, especially the anti-tumor and antipsychotic products. The products are sold in China and also exported to the USA, European and Indian markets. Credit-ChemWerth has established a high level quality system, successfully passed SFDA inspection for GMP compliance in 2007, 2008 and 2010, and also passed its first FDA overseas inspection in 2010. They have filed four DMF’s with the FDA, including Epinastine HCl, Temozolomide, Busulfan and Topotecan HCl, and will file another two in 2012. With the extensive support from ChemWerth, their customer was able to submit the first Epinastine HCl ANDA and received FDA approval in March 2011 with 180-day market exclusivity.
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. The strategic partnership significantly improves our ability to service our customers by further expanding our supply chain. Moreover, this partnership greatly reduces the product development cycle which help our customers be first to market.”