Raffles received a DMF filing confirmation letter from the FDA

Recently, Guangdong Raffles Pharmaceutical Technology Co., LTD. completed the DMF Type II registration of an API and has received a DMF confirmation letter from the United States Food and Drug Administration (hereinafter referred to as "FDA").

 At present, Raffles has completed the CDE API registration of 1 product and the FDA DMF Type II registration of 2 products, and is expected to usher in the National Bureau Verification Center and FDA audit by the end of 2023 and the end of 2025, respectively.

 A Drug Master File (DMF) is an archived, pending document submitted to the FDA that contains detailed information about manufacturing facilities, processes, quality control, and the raw materials and packaging materials used in the manufacturing, processing, packaging, and storage of a drug product for human use.