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