Registration Number : 217MF10040
Registrant's Address : 4-8-2 Nihonbashi Honcho, Chuo-ku, Tokyo
Initial Date of Registration : 2005-05-20
Latest Date of Registration : 2009-11-24
A Oxaprozin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Oxaprozin, including repackagers and relabelers. The FDA regulates Oxaprozin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Oxaprozin 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 Oxaprozin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Oxaprozin supplier is an individual or a company that provides Oxaprozin active pharmaceutical ingredient (API) or Oxaprozin finished formulations upon request. The Oxaprozin suppliers may include Oxaprozin API manufacturers, exporters, distributors and traders.
click here to find a list of Oxaprozin 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 Oxaprozin Drug Master File in Japan (Oxaprozin JDMF) empowers Oxaprozin 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 Oxaprozin JDMF during the approval evaluation for pharmaceutical products. At the time of Oxaprozin 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 Oxaprozin suppliers with JDMF on PharmaCompass.
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