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