01 1Polaris AI Pharma Corp.
01 1Apixaban
01 1South Korea
Registration Number : 306MF10141
Registrant's Address : 25, Barangongdan-ro, Hyangnam-eup, Hwaseong-si, Gyeonggi-do, Korea
Initial Date of Registration : 2024-11-13
Latest Date of Registration : 2024-11-13
A Apixaban manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Apixaban, including repackagers and relabelers. The FDA regulates Apixaban manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Apixaban API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Apixaban manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Apixaban supplier is an individual or a company that provides Apixaban active pharmaceutical ingredient (API) or Apixaban finished formulations upon request. The Apixaban suppliers may include Apixaban API manufacturers, exporters, distributors and traders.
click here to find a list of Apixaban suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Apixaban Drug Master File in Japan (Apixaban JDMF) empowers Apixaban API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Apixaban JDMF during the approval evaluation for pharmaceutical products. At the time of Apixaban JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Apixaban suppliers with JDMF on PharmaCompass.
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