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