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