In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Doconexent Drug Master File in Korea (Doconexent KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Doconexent. The MFDS reviews the Doconexent KDMF as part of the drug registration process and uses the information provided in the Doconexent KDMF to evaluate the safety and efficacy of the drug.
After submitting a Doconexent KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Doconexent API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Doconexent suppliers with KDMF on PharmaCompass.