01 2Tokyo Chemical Industry Co., Ltd.
01 1Methyl sulfate neostigmine
02 1Neostigmine bromide
01 2Japan
Registration Number : 217MF11160
Registrant's Address : 6-15-9 Toshima, Kita-ku, Tokyo
Initial Date of Registration : 2005-12-12
Latest Date of Registration : 2006-10-20
Registration Number : 217MF11158
Registrant's Address : 6-15-9 Toshima, Kita-ku, Tokyo
Initial Date of Registration : 2005-12-12
Latest Date of Registration : 2006-10-20
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A Ammonium, (m-hydroxyphenyl)trimethyl-, methyl sulfate, dimethylcarbamate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ammonium, (m-hydroxyphenyl)trimethyl-, methyl sulfate, dimethylcarbamate, including repackagers and relabelers. The FDA regulates Ammonium, (m-hydroxyphenyl)trimethyl-, methyl sulfate, dimethylcarbamate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ammonium, (m-hydroxyphenyl)trimethyl-, methyl sulfate, dimethylcarbamate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Ammonium, (m-hydroxyphenyl)trimethyl-, methyl sulfate, dimethylcarbamate supplier is an individual or a company that provides Ammonium, (m-hydroxyphenyl)trimethyl-, methyl sulfate, dimethylcarbamate active pharmaceutical ingredient (API) or Ammonium, (m-hydroxyphenyl)trimethyl-, methyl sulfate, dimethylcarbamate finished formulations upon request. The Ammonium, (m-hydroxyphenyl)trimethyl-, methyl sulfate, dimethylcarbamate suppliers may include Ammonium, (m-hydroxyphenyl)trimethyl-, methyl sulfate, dimethylcarbamate 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 Ammonium, (m-hydroxyphenyl)trimethyl-, methyl sulfate, dimethylcarbamate Drug Master File in Japan (Ammonium, (m-hydroxyphenyl)trimethyl-, methyl sulfate, dimethylcarbamate JDMF) empowers Ammonium, (m-hydroxyphenyl)trimethyl-, methyl sulfate, dimethylcarbamate 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 Ammonium, (m-hydroxyphenyl)trimethyl-, methyl sulfate, dimethylcarbamate JDMF during the approval evaluation for pharmaceutical products. At the time of Ammonium, (m-hydroxyphenyl)trimethyl-, methyl sulfate, dimethylcarbamate 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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