01 1Alps Pharmaceutical Co., Ltd.
01 1Magnesium L- aspartic acid, potassium
01 1Japan
Magnesium and potassium L-aspartate
Registration Number : 217MF11042
Registrant's Address : 2-10-50 Mukaimachi, Furukawa-cho, Hida-shi, Gifu Prefecture
Initial Date of Registration : 2005-12-02
Latest Date of Registration : 2009-07-30
A Magnesium Aspartate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Magnesium Aspartate, including repackagers and relabelers. The FDA regulates Magnesium Aspartate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Magnesium Aspartate 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 Magnesium Aspartate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Magnesium Aspartate supplier is an individual or a company that provides Magnesium Aspartate active pharmaceutical ingredient (API) or Magnesium Aspartate finished formulations upon request. The Magnesium Aspartate suppliers may include Magnesium Aspartate API manufacturers, exporters, distributors and traders.
click here to find a list of Magnesium Aspartate 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 Magnesium Aspartate Drug Master File in Japan (Magnesium Aspartate JDMF) empowers Magnesium Aspartate 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 Magnesium Aspartate JDMF during the approval evaluation for pharmaceutical products. At the time of Magnesium Aspartate 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 Magnesium Aspartate suppliers with JDMF on PharmaCompass.
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