In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a 1592U89 Drug Master File in Korea (1592U89 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 1592U89. The MFDS reviews the 1592U89 KDMF as part of the drug registration process and uses the information provided in the 1592U89 KDMF to evaluate the safety and efficacy of the drug.
After submitting a 1592U89 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 1592U89 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of 1592U89 suppliers with KDMF on PharmaCompass.