01 1Ohara Pharmaceutical Co., Ltd.
02 1Sanpo Chemical Industry Co., Ltd.
01 1Ameji methylsulfate sulfate (manufactured only)
02 1Methyl sulfate amezinium
01 2Japan
Amezinium methylsulfate (for manufacturing purposes only)
Registration Number : 221MF10217
Registrant's Address : 7-30-7 Toshima, Kita-ku, Tokyo
Initial Date of Registration : 2009-09-30
Latest Date of Registration : 2009-09-30
Registration Number : 217MF11219
Registrant's Address : 121-15 Torino, Koka-cho, Koka City, Shiga Prefecture
Initial Date of Registration : 2005-12-12
Latest Date of Registration : 2006-10-20
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PharmaCompass offers a list of Supratonin 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 Supratonin manufacturer or Supratonin supplier for your needs.
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A 03NR868ICX manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 03NR868ICX, including repackagers and relabelers. The FDA regulates 03NR868ICX manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 03NR868ICX 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 03NR868ICX supplier is an individual or a company that provides 03NR868ICX active pharmaceutical ingredient (API) or 03NR868ICX finished formulations upon request. The 03NR868ICX suppliers may include 03NR868ICX 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 03NR868ICX Drug Master File in Japan (03NR868ICX JDMF) empowers 03NR868ICX 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 03NR868ICX JDMF during the approval evaluation for pharmaceutical products. At the time of 03NR868ICX 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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