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