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