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.
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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, I-125 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fibrinogen, I-125, including repackagers and relabelers. The FDA regulates Fibrinogen, I-125 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fibrinogen, I-125 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, I-125 supplier is an individual or a company that provides Fibrinogen, I-125 active pharmaceutical ingredient (API) or Fibrinogen, I-125 finished formulations upon request. The Fibrinogen, I-125 suppliers may include Fibrinogen, I-125 API manufacturers, exporters, distributors and traders.
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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, I-125 Drug Master File in Japan (Fibrinogen, I-125 JDMF) empowers Fibrinogen, I-125 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, I-125 JDMF during the approval evaluation for pharmaceutical products. At the time of Fibrinogen, I-125 JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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