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