01 1Wuhan Wuyao Pharmaceutical Co. , Ltd.
02 1Yashiro Pharmaceutical Co., Ltd.
01 2Sulpyrine hydrate
01 1China
02 1Blank
Registration Number : 229MF10033
Registrant's Address : Room No. 1-6, Floor 23, Building 1#, No. 160 Qiaokou Road Qiaokou District
Initial Date of Registration : 2017-02-08
Latest Date of Registration : 2017-02-08
Registration Number : 222MF10084
Registrant's Address : 10-2 Yoshida Shimojima, Higashiosaka City, Osaka Prefecture
Initial Date of Registration : 2010-03-16
Latest Date of Registration : 2010-03-16
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A Novaminsulfone sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Novaminsulfone sodium, including repackagers and relabelers. The FDA regulates Novaminsulfone sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Novaminsulfone sodium 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 Novaminsulfone sodium supplier is an individual or a company that provides Novaminsulfone sodium active pharmaceutical ingredient (API) or Novaminsulfone sodium finished formulations upon request. The Novaminsulfone sodium suppliers may include Novaminsulfone sodium 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 Novaminsulfone sodium Drug Master File in Japan (Novaminsulfone sodium JDMF) empowers Novaminsulfone sodium 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 Novaminsulfone sodium JDMF during the approval evaluation for pharmaceutical products. At the time of Novaminsulfone sodium 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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