01 1Taihei Chemical Industry Co., Ltd.
01 1Japan Pharmaceutical Codex dihydrogen phosphate potassium (production only)
01 1Japan
Registration Number : 221MF10233
Registrant's Address : 1-16 Higashi-Koraibashi, Chuo-ku, Osaka City, Osaka Prefecture
Initial Date of Registration : 2009-10-26
Latest Date of Registration : 2016-09-02
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A natriumdihydrogen-phosphate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of natriumdihydrogen-phosphate, including repackagers and relabelers. The FDA regulates natriumdihydrogen-phosphate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. natriumdihydrogen-phosphate 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 natriumdihydrogen-phosphate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A natriumdihydrogen-phosphate supplier is an individual or a company that provides natriumdihydrogen-phosphate active pharmaceutical ingredient (API) or natriumdihydrogen-phosphate finished formulations upon request. The natriumdihydrogen-phosphate suppliers may include natriumdihydrogen-phosphate API manufacturers, exporters, distributors and traders.
click here to find a list of natriumdihydrogen-phosphate suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA 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 natriumdihydrogen-phosphate Drug Master File in Japan (natriumdihydrogen-phosphate JDMF) empowers natriumdihydrogen-phosphate 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 natriumdihydrogen-phosphate JDMF during the approval evaluation for pharmaceutical products. At the time of natriumdihydrogen-phosphate 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 natriumdihydrogen-phosphate suppliers with JDMF on PharmaCompass.
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