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