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