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