01 1Katsura Chemical Co., Ltd.
01 1Tetrahydrozoline nitrate
01 1Japan
Registration Number : 221MF10147
Registrant's Address : 4-15-19 Hibarigaoka, Zama City, Kanagawa Prefecture
Initial Date of Registration : 2009-07-09
Latest Date of Registration : 2009-07-09
A Tetrahydrozoline nitrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tetrahydrozoline nitrate, including repackagers and relabelers. The FDA regulates Tetrahydrozoline nitrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tetrahydrozoline nitrate 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 Tetrahydrozoline nitrate supplier is an individual or a company that provides Tetrahydrozoline nitrate active pharmaceutical ingredient (API) or Tetrahydrozoline nitrate finished formulations upon request. The Tetrahydrozoline nitrate suppliers may include Tetrahydrozoline nitrate API manufacturers, exporters, distributors and traders.
click here to find a list of Tetrahydrozoline nitrate 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 Tetrahydrozoline nitrate Drug Master File in Japan (Tetrahydrozoline nitrate JDMF) empowers Tetrahydrozoline nitrate 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 Tetrahydrozoline nitrate JDMF during the approval evaluation for pharmaceutical products. At the time of Tetrahydrozoline nitrate 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 Tetrahydrozoline nitrate suppliers with JDMF on PharmaCompass.
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