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