In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a 483-63-6 Drug Master File in Korea (483-63-6 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 483-63-6. The MFDS reviews the 483-63-6 KDMF as part of the drug registration process and uses the information provided in the 483-63-6 KDMF to evaluate the safety and efficacy of the drug.
After submitting a 483-63-6 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 483-63-6 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of 483-63-6 suppliers with KDMF on PharmaCompass.