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 Eliquis manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Eliquis, including repackagers and relabelers. The FDA regulates Eliquis manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Eliquis 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 Eliquis manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Eliquis supplier is an individual or a company that provides Eliquis active pharmaceutical ingredient (API) or Eliquis finished formulations upon request. The Eliquis suppliers may include Eliquis API manufacturers, exporters, distributors and traders.
click here to find a list of Eliquis 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 Eliquis Drug Master File in Japan (Eliquis JDMF) empowers Eliquis 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 Eliquis JDMF during the approval evaluation for pharmaceutical products. At the time of Eliquis 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 Eliquis suppliers with JDMF on PharmaCompass.
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