In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a E262 Drug Master File in Korea (E262 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of E262. The MFDS reviews the E262 KDMF as part of the drug registration process and uses the information provided in the E262 KDMF to evaluate the safety and efficacy of the drug.
After submitting a E262 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 E262 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of E262 suppliers with KDMF on PharmaCompass.