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