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