01 1Sakai Chemical Industry Co., Ltd.
01 1Japanese Pharmacopoeia barium sulfate (production only)
01 1Japan
Japanese Pharmacopoeia Barium Sulfate (for manufacturing purposes only)
Registration Number : 217MF10466
Registrant's Address : 5-2 Ebisujimacho, Sakai-ku, Sakai City, Osaka Prefecture
Initial Date of Registration : 2005-08-24
Latest Date of Registration : 2007-07-02
A Barium Sulfate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Barium Sulfate, including repackagers and relabelers. The FDA regulates Barium Sulfate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Barium Sulfate 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 Barium Sulfate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Barium Sulfate supplier is an individual or a company that provides Barium Sulfate active pharmaceutical ingredient (API) or Barium Sulfate finished formulations upon request. The Barium Sulfate suppliers may include Barium Sulfate API manufacturers, exporters, distributors and traders.
click here to find a list of Barium Sulfate 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 Barium Sulfate Drug Master File in Japan (Barium Sulfate JDMF) empowers Barium Sulfate 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 Barium Sulfate JDMF during the approval evaluation for pharmaceutical products. At the time of Barium Sulfate 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 Barium Sulfate suppliers with JDMF on PharmaCompass.
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