01 1Ohara Pharmaceutical Co., Ltd.
02 1Sanbo 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 Toriiino, Koka-cho, Koka City, Shiga Prefecture
Initial Date of Registration : 2005-12-12
Latest Date of Registration : 2006-10-20
A Supratonin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Supratonin, including repackagers and relabelers. The FDA regulates Supratonin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Supratonin 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 Supratonin supplier is an individual or a company that provides Supratonin active pharmaceutical ingredient (API) or Supratonin finished formulations upon request. The Supratonin suppliers may include Supratonin API manufacturers, exporters, distributors and traders.
click here to find a list of Supratonin 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 Supratonin Drug Master File in Japan (Supratonin JDMF) empowers Supratonin 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 Supratonin JDMF during the approval evaluation for pharmaceutical products. At the time of Supratonin 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 Supratonin suppliers with JDMF on PharmaCompass.
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