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