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