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