01 1Kobe Natural Products Chemical Co., Ltd.
02 1Permakem Asia Co., Ltd.
01 1Bromide distigmine
02 1Distigmine bromide
01 2Japan
Registration Number : 226MF10223
Registrant's Address : 3-2-34 Takatsukadai, Nishi-ku, Kobe City, Hyogo Prefecture
Initial Date of Registration : 2014-12-08
Latest Date of Registration : 2017-04-25
Registration Number : 217MF10705
Registrant's Address : 1-10-11, Nihonbashi Horidomecho, Chuo-ku, Tokyo
Initial Date of Registration : 2005-10-07
Latest Date of Registration : 2008-10-10
A Distigmine Bromide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Distigmine Bromide, including repackagers and relabelers. The FDA regulates Distigmine Bromide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Distigmine Bromide 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 Distigmine Bromide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Distigmine Bromide supplier is an individual or a company that provides Distigmine Bromide active pharmaceutical ingredient (API) or Distigmine Bromide finished formulations upon request. The Distigmine Bromide suppliers may include Distigmine Bromide API manufacturers, exporters, distributors and traders.
click here to find a list of Distigmine Bromide 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 Distigmine Bromide Drug Master File in Japan (Distigmine Bromide JDMF) empowers Distigmine Bromide 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 Distigmine Bromide JDMF during the approval evaluation for pharmaceutical products. At the time of Distigmine Bromide 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 Distigmine Bromide suppliers with JDMF on PharmaCompass.
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