In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a NORGESIC FORTE-2 Drug Master File in Korea (NORGESIC FORTE-2 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of NORGESIC FORTE-2. The MFDS reviews the NORGESIC FORTE-2 KDMF as part of the drug registration process and uses the information provided in the NORGESIC FORTE-2 KDMF to evaluate the safety and efficacy of the drug.
After submitting a NORGESIC FORTE-2 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 NORGESIC FORTE-2 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of NORGESIC FORTE-2 suppliers with KDMF on PharmaCompass.