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