01 1Sekisui Medical Co., Ltd.
01 1Para-hippuric acid sodium
01 1Japan
Registration Number : 217MF10775
Registrant's Address : 2-1-3 Nihonbashi, Chuo-ku, Tokyo
Initial Date of Registration : 2005-10-20
Latest Date of Registration : 2010-02-04
A Aminohippuric Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Aminohippuric Acid, including repackagers and relabelers. The FDA regulates Aminohippuric Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Aminohippuric Acid 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 Aminohippuric Acid supplier is an individual or a company that provides Aminohippuric Acid active pharmaceutical ingredient (API) or Aminohippuric Acid finished formulations upon request. The Aminohippuric Acid suppliers may include Aminohippuric Acid API manufacturers, exporters, distributors and traders.
click here to find a list of Aminohippuric Acid 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 Aminohippuric Acid Drug Master File in Japan (Aminohippuric Acid JDMF) empowers Aminohippuric Acid 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 Aminohippuric Acid JDMF during the approval evaluation for pharmaceutical products. At the time of Aminohippuric Acid 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 Aminohippuric Acid suppliers with JDMF on PharmaCompass.
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