July 2017: ChemWerth Inc. and Hubei Enoray Biopharmaceutical Co., Ltd. (Enoray) are pleased to announce that Enoray has passed their second U.S. FDA inspection in July, 2017 with no 483 issued. The FDA inspection focused on Heparin API. ChemWerth has worked closely with Enoray over the past three years, through extensive on-site training, audits, as well as providing sound technical support, to ensure that their operations are fully cGMP compliant. Enoray was established in 2010 and mainly produces FDA/EU grade Heparin, Enoxaparin, and other low molecular weight Heparins based on its own vertically integrated production operation from traceable porcine derived starting materials through API manufacturing in dedicated facilities. ChemWerth is Enoray’s U.S. Site Agent as well as its Regulatory Agent for multiple Drug Master Files (DMFs) including Heparin Crude, Heparin API, and Enoxaparin API.
