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