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