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