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