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