In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a LP00276 Drug Master File in Korea (LP00276 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of LP00276. The MFDS reviews the LP00276 KDMF as part of the drug registration process and uses the information provided in the LP00276 KDMF to evaluate the safety and efficacy of the drug.
After submitting a LP00276 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 LP00276 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of LP00276 suppliers with KDMF on PharmaCompass.