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