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