ChemWerth Files its 500th Drug Master File with FDA

ChemWerth Inc., a supplier of generic active pharmaceutical ingredients (APIs), filed a Drug Master File (DMF) with the U.S. Food and Drug Administration (FDA) for Clevidipine, making it the company’s 500th DMF in its history. It filed its first DMF in 1987 and continues to rank among world leaders for DMFs available for reference.

According to the company, its average review cycle for DMF filings is 0.79 in comparison with the industry average of 2.5 cycles, enabling it to turn DMFs around quickly to provide customers with an early-to-market advantage.

“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 is a full-service API supplier with capabilities to support both large and small finished dosage companies worldwide. Through exclusive development and partnerships with API manufacturers, the company has a proprietary product selection process and extensive product portfolio.