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