ChemWerth Files its 500th Drug Master File with FDA


July 15, 2020


ChemWerth Files its 500th Drug Master File with FDA

Woodbridge, Conn. – ChemWerth Inc., a leading supplier of generic Active Pharmaceutical Ingredients (APIs), filed a Drug Master File (DMF) with the Food and Drug Administration (FDA) for Clevidipine, making it the company’s 500th DMF in its history. ChemWerth filed its first DMF in 1987 and continues to rank among world leaders for DMFs available for reference.


The achievement of 500 DMFs represents ChemWerth’s staying power over 38 years, and is a testament to the company’s regulatory and compliance prowess. ChemWerth’s average review cycle for DMF filings is just 0.79 in comparison with the industry average of 2.5 cycles. The efficiency in review cycles enables ChemWerth to turn DMFs around quickly to provide customers with an early-to-market advantage, which can lead to significant market share and revenue opportunity.


“Speed to market is paramount to succeed in the pharmaceutical landscape. Our regulatory experience and expertise helps us get the filing right the first time with 44% of the filings accepted in the initial pass,” said Peter Werth, president and founder, ChemWerth. “Our best-in-class regulatory team is dedicated to delivering exceptional value for our customers.”


ChemWerth provides high-quality APIs to regulated markets worldwide. Unlike trader-brokers, ChemWerth is a full-service API supplier with capabilities to support both large and small finished dosage companies. Through exclusive development and partnerships with API manufacturers, the company has a proprietary product selection process and extensive product portfolio.


About ChemWerth Inc.: Founded in 1982, ChemWerth is a world leader in developing and supplying specialty generic Active Pharmaceutical Ingredients (APIs) for human and animal health markets worldwide. The company continues to rank among world leaders for DMFs available for reference. ChemWerth is the regulatory agent for 25-plus FDA-approved facilities in the United States, Europe, India and China. The company sells 100-plus products in 38 countries around the globe. For more information about the company, please visit

ChemWerth and Enoray announce that Enoray has passed second U.S. FDA inspection

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.

Enoray Picture