01 1SperaNexus Inc.
01 1Tosylate suplatast
01 1Japan
Registration Number : 218MF10274
Registrant's Address : 4-8-2 Nihonbashi Honcho, Chuo-ku, Tokyo
Initial Date of Registration : 2006-02-23
Latest Date of Registration : 2006-10-20
A Suplatast manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Suplatast, including repackagers and relabelers. The FDA regulates Suplatast manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Suplatast 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 Suplatast supplier is an individual or a company that provides Suplatast active pharmaceutical ingredient (API) or Suplatast finished formulations upon request. The Suplatast suppliers may include Suplatast API manufacturers, exporters, distributors and traders.
click here to find a list of Suplatast 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 Suplatast Drug Master File in Japan (Suplatast JDMF) empowers Suplatast 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 Suplatast JDMF during the approval evaluation for pharmaceutical products. At the time of Suplatast 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 Suplatast suppliers with JDMF on PharmaCompass.
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