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