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