In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Durcal 10 Drug Master File in Korea (Durcal 10 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Durcal 10. The MFDS reviews the Durcal 10 KDMF as part of the drug registration process and uses the information provided in the Durcal 10 KDMF to evaluate the safety and efficacy of the drug.
After submitting a Durcal 10 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 Durcal 10 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Durcal 10 suppliers with KDMF on PharmaCompass.