01 1SperaNexus Inc.
02 1Yashiro Pharmaceutical Co., Ltd.
01 2Next gallic acid bismuth
01 1Japan
02 1Blank
Registration Number : 217MF10033
Registrant's Address : 4-8-2 Nihonbashi Honcho, Chuo-ku, Tokyo
Initial Date of Registration : 2005-05-20
Latest Date of Registration : 2006-09-22
Registration Number : 218MF10240
Registrant's Address : 10-2 Yoshida Shimojima, Higashiosaka City, Osaka Prefecture
Initial Date of Registration : 2006-02-16
Latest Date of Registration : 2010-03-23
A Bismuth Subgallate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bismuth Subgallate, including repackagers and relabelers. The FDA regulates Bismuth Subgallate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bismuth Subgallate 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 Bismuth Subgallate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bismuth Subgallate supplier is an individual or a company that provides Bismuth Subgallate active pharmaceutical ingredient (API) or Bismuth Subgallate finished formulations upon request. The Bismuth Subgallate suppliers may include Bismuth Subgallate API manufacturers, exporters, distributors and traders.
click here to find a list of Bismuth Subgallate 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 Bismuth Subgallate Drug Master File in Japan (Bismuth Subgallate JDMF) empowers Bismuth Subgallate 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 Bismuth Subgallate JDMF during the approval evaluation for pharmaceutical products. At the time of Bismuth Subgallate 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 Bismuth Subgallate suppliers with JDMF on PharmaCompass.
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