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