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