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