01 1Osaka Synthetic Organic Chemistry Laboratory Co., Ltd.
01 1Stand spiron citrate production dedicated
01 1Japan
Tandospirone citrate For manufacturing purposes only
Registration Number : 228MF10016
Registrant's Address : 1-1-2 Nishinomiyahama, Nishinomiya City, Hyogo Prefecture
Initial Date of Registration : 2016-01-08
Latest Date of Registration : 2016-01-08
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PharmaCompass offers a list of Ferric Citrate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Ferric Citrate manufacturer or Ferric Citrate supplier for your needs.
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PharmaCompass also assists you with knowing the Ferric Citrate API Price utilized in the formulation of products. Ferric Citrate API Price is not always fixed or binding as the Ferric Citrate Price is obtained through a variety of data sources. The Ferric Citrate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A AURYXIA manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of AURYXIA, including repackagers and relabelers. The FDA regulates AURYXIA manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. AURYXIA API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A AURYXIA supplier is an individual or a company that provides AURYXIA active pharmaceutical ingredient (API) or AURYXIA finished formulations upon request. The AURYXIA suppliers may include AURYXIA API manufacturers, exporters, distributors and traders.
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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 AURYXIA Drug Master File in Japan (AURYXIA JDMF) empowers AURYXIA 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 AURYXIA JDMF during the approval evaluation for pharmaceutical products. At the time of AURYXIA JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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