01 1Taihei Chemical Industry Co., Ltd.
01 1Japanese Pharmaceutical Codex potassium dihydrogen phosphate (manufactured only)
01 1Japan
Japanese Pharmacopoeia Non-Drug Standard Potassium Dihydrogen Phosphate (For manufacturing only)
Registration Number : 218MF10726
Registrant's Address : Osaka Prefecture, Osaka City, Chuo Ward, Higashi-Koraibashi 1-16
Initial Date of Registration : 2006-09-06
Latest Date of Registration : 2006-09-06
A Potassium phosphate monobasic manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Potassium phosphate monobasic, including repackagers and relabelers. The FDA regulates Potassium phosphate monobasic manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Potassium phosphate monobasic API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Potassium phosphate monobasic manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Potassium phosphate monobasic supplier is an individual or a company that provides Potassium phosphate monobasic active pharmaceutical ingredient (API) or Potassium phosphate monobasic finished formulations upon request. The Potassium phosphate monobasic suppliers may include Potassium phosphate monobasic API manufacturers, exporters, distributors and traders.
click here to find a list of Potassium phosphate monobasic 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 Potassium phosphate monobasic Drug Master File in Japan (Potassium phosphate monobasic JDMF) empowers Potassium phosphate monobasic 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 Potassium phosphate monobasic JDMF during the approval evaluation for pharmaceutical products. At the time of Potassium phosphate monobasic 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 Potassium phosphate monobasic suppliers with JDMF on PharmaCompass.
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