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