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