In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a D00987 Drug Master File in Korea (D00987 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of D00987. The MFDS reviews the D00987 KDMF as part of the drug registration process and uses the information provided in the D00987 KDMF to evaluate the safety and efficacy of the drug.
After submitting a D00987 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 D00987 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of D00987 suppliers with KDMF on PharmaCompass.