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