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