In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a E170 Drug Master File in Korea (E170 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of E170. The MFDS reviews the E170 KDMF as part of the drug registration process and uses the information provided in the E170 KDMF to evaluate the safety and efficacy of the drug.
After submitting a E170 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 E170 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of E170 suppliers with KDMF on PharmaCompass.