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