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