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