In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a 1,25-Dihydroxy-5,6-trans-vitamin D3 Drug Master File in Korea (1,25-Dihydroxy-5,6-trans-vitamin D3 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 1,25-Dihydroxy-5,6-trans-vitamin D3. The MFDS reviews the 1,25-Dihydroxy-5,6-trans-vitamin D3 KDMF as part of the drug registration process and uses the information provided in the 1,25-Dihydroxy-5,6-trans-vitamin D3 KDMF to evaluate the safety and efficacy of the drug.
After submitting a 1,25-Dihydroxy-5,6-trans-vitamin D3 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 1,25-Dihydroxy-5,6-trans-vitamin D3 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of 1,25-Dihydroxy-5,6-trans-vitamin D3 suppliers with KDMF on PharmaCompass.