01 1Daito Co., Ltd.
01 1Outsiders regulations tripamide (production only)
01 1Japan
Extra-official regulations Tripamid (for manufacturing only)
Registration Number : 217MF10659
Registrant's Address : 326 Yokamachi, Toyama City, Toyama Prefecture
Initial Date of Registration : 2005-09-29
Latest Date of Registration : 2009-04-22
A Tripamide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tripamide, including repackagers and relabelers. The FDA regulates Tripamide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tripamide 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 Tripamide supplier is an individual or a company that provides Tripamide active pharmaceutical ingredient (API) or Tripamide finished formulations upon request. The Tripamide suppliers may include Tripamide API manufacturers, exporters, distributors and traders.
click here to find a list of Tripamide 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 Tripamide Drug Master File in Japan (Tripamide JDMF) empowers Tripamide 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 Tripamide JDMF during the approval evaluation for pharmaceutical products. At the time of Tripamide 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 Tripamide suppliers with JDMF on PharmaCompass.
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