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