01 1KM Biologics Co., Ltd.
01 1Human blood coagulation factor XIII drug substance
01 1Japan
Human blood coagulation factor XIII active pharmaceutical ingredient
Registration Number : 227MF10084
Registrant's Address : 1-6-1 Okubo, Kita-ku, Kumamoto City, Kumamoto Prefecture
Initial Date of Registration : 2015-03-12
Latest Date of Registration : 2016-03-23
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PharmaCompass offers a list of Calcium Ion API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Calcium Ion manufacturer or Calcium Ion supplier for your needs.
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A Calcium(2+)ions manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Calcium(2+)ions, including repackagers and relabelers. The FDA regulates Calcium(2+)ions manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Calcium(2+)ions API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Calcium(2+)ions supplier is an individual or a company that provides Calcium(2+)ions active pharmaceutical ingredient (API) or Calcium(2+)ions finished formulations upon request. The Calcium(2+)ions suppliers may include Calcium(2+)ions API manufacturers, exporters, distributors and traders.
click here to find a list of Calcium(2+)ions 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 Calcium(2+)ions Drug Master File in Japan (Calcium(2+)ions JDMF) empowers Calcium(2+)ions 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 Calcium(2+)ions JDMF during the approval evaluation for pharmaceutical products. At the time of Calcium(2+)ions 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 Calcium(2+)ions suppliers with JDMF on PharmaCompass.
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