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