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