01 1Kongo Chemical Co., Ltd.
01 1Hydrochloric acid eprazinone (production only)
01 1Japan
Eprazinone Hydrochloride (for manufacturing purposes only)
Registration Number : 217MF11193
Registrant's Address : 3 Himata, Toyama City, Toyama Prefecture
Initial Date of Registration : 2005-12-12
Latest Date of Registration : 2010-03-09
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PharmaCompass offers a list of 10402-53-6 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 10402-53-6 manufacturer or 10402-53-6 supplier for your needs.
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A Eprazinone HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Eprazinone HCl, including repackagers and relabelers. The FDA regulates Eprazinone HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Eprazinone HCl 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 Eprazinone HCl supplier is an individual or a company that provides Eprazinone HCl active pharmaceutical ingredient (API) or Eprazinone HCl finished formulations upon request. The Eprazinone HCl suppliers may include Eprazinone HCl 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 Eprazinone HCl Drug Master File in Japan (Eprazinone HCl JDMF) empowers Eprazinone HCl 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 Eprazinone HCl JDMF during the approval evaluation for pharmaceutical products. At the time of Eprazinone HCl 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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