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