Registration Number : 217MF10868
Registrant's Address : 1978-96 Ogushi, Ube City, Yamaguchi Prefecture
Initial Date of Registration : 2005-11-07
Latest Date of Registration : 2009-12-18
A Sarmentose manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sarmentose, including repackagers and relabelers. The FDA regulates Sarmentose manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sarmentose 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 Sarmentose supplier is an individual or a company that provides Sarmentose active pharmaceutical ingredient (API) or Sarmentose finished formulations upon request. The Sarmentose suppliers may include Sarmentose API manufacturers, exporters, distributors and traders.
click here to find a list of Sarmentose 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 Sarmentose Drug Master File in Japan (Sarmentose JDMF) empowers Sarmentose 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 Sarmentose JDMF during the approval evaluation for pharmaceutical products. At the time of Sarmentose 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 Sarmentose suppliers with JDMF on PharmaCompass.
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