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