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