In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Dietil retard Drug Master File in Korea (Dietil retard KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Dietil retard. The MFDS reviews the Dietil retard KDMF as part of the drug registration process and uses the information provided in the Dietil retard KDMF to evaluate the safety and efficacy of the drug.
After submitting a Dietil retard 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 Dietil retard API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Dietil retard suppliers with KDMF on PharmaCompass.