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