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