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