01 1Alps Pharmaceutical Co., Ltd.
01 1Potassium cresol sulfonic acid
01 1Japan
Registration Number : 217MF11059
Registrant's Address : 2-10-50 Mukaimachi, Furukawa-cho, Hida-shi, Gifu Prefecture
Initial Date of Registration : 2005-12-02
Latest Date of Registration : 2009-10-26
A Potassium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Potassium, including repackagers and relabelers. The FDA regulates Potassium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Potassium 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 Potassium supplier is an individual or a company that provides Potassium active pharmaceutical ingredient (API) or Potassium finished formulations upon request. The Potassium suppliers may include Potassium API manufacturers, exporters, distributors and traders.
click here to find a list of Potassium 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 Drug Master File in Japan (Potassium JDMF) empowers Potassium 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 JDMF during the approval evaluation for pharmaceutical products. At the time of Potassium 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 suppliers with JDMF on PharmaCompass.
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