01 1Speranexus Co., Ltd.
02 1Yamamoto Chemical Industry Co., Ltd.
01 2Ethenzamide
01 2Japan
Registration Number : 217MF10029
Registrant's Address : 4-8-2 Nihonbashi Honcho, Chuo-ku, Tokyo
Initial Date of Registration : 2005-05-20
Latest Date of Registration : 2007-09-18
Registration Number : 223MF10045
Registrant's Address : 1-4 Funatsu-cho, Wakayama City, Wakayama Prefecture
Initial Date of Registration : 2011-03-25
Latest Date of Registration : 2011-03-25
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A Ethenzamid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ethenzamid, including repackagers and relabelers. The FDA regulates Ethenzamid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ethenzamid 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 Ethenzamid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Ethenzamid supplier is an individual or a company that provides Ethenzamid active pharmaceutical ingredient (API) or Ethenzamid finished formulations upon request. The Ethenzamid suppliers may include Ethenzamid API manufacturers, exporters, distributors and traders.
click here to find a list of Ethenzamid 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 Ethenzamid Drug Master File in Japan (Ethenzamid JDMF) empowers Ethenzamid 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 Ethenzamid JDMF during the approval evaluation for pharmaceutical products. At the time of Ethenzamid 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 Ethenzamid suppliers with JDMF on PharmaCompass.
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