01 2Permakem Asia Co., Ltd.
01 2Bethanechol chloride
01 2Japan
Registration Number : 217MF10710
Registrant's Address : 1-10-11, Nihonbashi Horidomecho, Chuo-ku, Tokyo
Initial Date of Registration : 2005-10-07
Latest Date of Registration : 2009-08-07
Registration Number : 224MF10220
Registrant's Address : 1-10-11, Nihonbashi Horidomecho, Chuo-ku, Tokyo
Initial Date of Registration : 2012-11-19
Latest Date of Registration : 2012-11-19
A Bethanechol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bethanechol, including repackagers and relabelers. The FDA regulates Bethanechol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bethanechol 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 Bethanechol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bethanechol supplier is an individual or a company that provides Bethanechol active pharmaceutical ingredient (API) or Bethanechol finished formulations upon request. The Bethanechol suppliers may include Bethanechol API manufacturers, exporters, distributors and traders.
click here to find a list of Bethanechol 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 Bethanechol Drug Master File in Japan (Bethanechol JDMF) empowers Bethanechol 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 Bethanechol JDMF during the approval evaluation for pharmaceutical products. At the time of Bethanechol 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 Bethanechol suppliers with JDMF on PharmaCompass.
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