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