01 1Kyowa Pharma Chemical Co., Ltd.
02 1Vifor (International) Inc.
01 1Japan Pharmaceutical Codex sugar-containing iron oxide (production only)
02 1Sucroferric oxyhydroxide
01 1Japan
02 1Switzerland
Registration Number : 226MF10218
Registrant's Address : Rechenstrasse 37, CH-9001 St. Gallen
Initial Date of Registration : 2014-11-17
Latest Date of Registration : 2023-09-06
Japanese Pharmacopoeia Non-Drug Standard Sugar-containing Iron Oxide (For manufacturing only)
Registration Number : 217MF10117
Registrant's Address : 530 Chokeiji, Takaoka City, Toyama Prefecture
Initial Date of Registration : 2005-05-24
Latest Date of Registration : 2009-04-08
A Oxoiron manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Oxoiron, including repackagers and relabelers. The FDA regulates Oxoiron manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Oxoiron API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Oxoiron supplier is an individual or a company that provides Oxoiron active pharmaceutical ingredient (API) or Oxoiron finished formulations upon request. The Oxoiron suppliers may include Oxoiron API manufacturers, exporters, distributors and traders.
click here to find a list of Oxoiron 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 Oxoiron Drug Master File in Japan (Oxoiron JDMF) empowers Oxoiron 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 Oxoiron JDMF during the approval evaluation for pharmaceutical products. At the time of Oxoiron 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 Oxoiron suppliers with JDMF on PharmaCompass.
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