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