01 1KM Biologics Co., Ltd.
01 1Human fibrinogen drug
01 1Japan
Human fibrinogen drug substance
Registration Number : 227MF10083
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 Fibrinogen 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 Fibrinogen manufacturer or Fibrinogen supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Fibrinogen manufacturer or Fibrinogen supplier.
PharmaCompass also assists you with knowing the Fibrinogen API Price utilized in the formulation of products. Fibrinogen API Price is not always fixed or binding as the Fibrinogen Price is obtained through a variety of data sources. The Fibrinogen Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Fibrinogen manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fibrinogen, including repackagers and relabelers. The FDA regulates Fibrinogen manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fibrinogen 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 Fibrinogen supplier is an individual or a company that provides Fibrinogen active pharmaceutical ingredient (API) or Fibrinogen finished formulations upon request. The Fibrinogen suppliers may include Fibrinogen API manufacturers, exporters, distributors and traders.
click here to find a list of Fibrinogen 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 Fibrinogen Drug Master File in Japan (Fibrinogen JDMF) empowers Fibrinogen 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 Fibrinogen JDMF during the approval evaluation for pharmaceutical products. At the time of Fibrinogen 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 Fibrinogen suppliers with JDMF on PharmaCompass.
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