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