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