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