In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a E333 Drug Master File in Korea (E333 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of E333. The MFDS reviews the E333 KDMF as part of the drug registration process and uses the information provided in the E333 KDMF to evaluate the safety and efficacy of the drug.
After submitting a E333 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 E333 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of E333 suppliers with KDMF on PharmaCompass.