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