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