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