01 1KM Biologics Co., Ltd.
01 1Human blood coagulation factor XIII drug substance
01 1Japan
Human blood coagulation factor ⅩⅢ drug substance
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, Price,and more, enabling you to easily find the right Calcium Ion manufacturer or Calcium Ion supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Calcium Ion manufacturer or Calcium Ion supplier.
PharmaCompass also assists you with knowing the Calcium Ion API Price utilized in the formulation of products. Calcium Ion API Price is not always fixed or binding as the Calcium Ion Price is obtained through a variety of data sources. The Calcium Ion Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Calcium Ion manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Calcium Ion, including repackagers and relabelers. The FDA regulates Calcium Ion manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Calcium Ion 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 Ion supplier is an individual or a company that provides Calcium Ion active pharmaceutical ingredient (API) or Calcium Ion finished formulations upon request. The Calcium Ion suppliers may include Calcium Ion API manufacturers, exporters, distributors and traders.
click here to find a list of Calcium Ion 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 Calcium Ion Drug Master File in Japan (Calcium Ion JDMF) empowers Calcium Ion 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 Ion JDMF during the approval evaluation for pharmaceutical products. At the time of Calcium Ion 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 Ion suppliers with JDMF on PharmaCompass.
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