01 1Organic Synthetic Chemicals Co., Ltd.
01 1Fudostein "Yuki"
01 1Japan
Registration Number : 217MF10816
Registrant's Address : 3-10-4 Nihonbashi Ningyocho, Chuo-ku, Tokyo
Initial Date of Registration : 2005-11-01
Latest Date of Registration : 2008-09-29
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PharmaCompass offers a list of Fudosteine 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 Fudosteine manufacturer or Fudosteine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Fudosteine manufacturer or Fudosteine supplier.
PharmaCompass also assists you with knowing the Fudosteine API Price utilized in the formulation of products. Fudosteine API Price is not always fixed or binding as the Fudosteine Price is obtained through a variety of data sources. The Fudosteine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Spelear manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Spelear, including repackagers and relabelers. The FDA regulates Spelear manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Spelear 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 Spelear supplier is an individual or a company that provides Spelear active pharmaceutical ingredient (API) or Spelear finished formulations upon request. The Spelear suppliers may include Spelear API manufacturers, exporters, distributors and traders.
click here to find a list of Spelear 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 Spelear Drug Master File in Japan (Spelear JDMF) empowers Spelear 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 Spelear JDMF during the approval evaluation for pharmaceutical products. At the time of Spelear 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 Spelear suppliers with JDMF on PharmaCompass.
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