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