01 1BIOFAC A/S
02 1KM Biologics Co., Ltd.
01 1Human thrombin drug
02 1Thrombin (production only)
01 1Denmark
02 1Japan
Thrombin (for manufacturing only)
Registration Number : 219MF10327
Registrant's Address : 350-356 Englandsvej, DK-2770 Kastrup Denmark
Initial Date of Registration : 2007-11-05
Latest Date of Registration : 2017-08-29
Registration Number : 227MF10085
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
A Thrombin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Thrombin, including repackagers and relabelers. The FDA regulates Thrombin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Thrombin 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 Thrombin supplier is an individual or a company that provides Thrombin active pharmaceutical ingredient (API) or Thrombin finished formulations upon request. The Thrombin suppliers may include Thrombin API manufacturers, exporters, distributors and traders.
click here to find a list of Thrombin 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 Thrombin Drug Master File in Japan (Thrombin JDMF) empowers Thrombin 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 Thrombin JDMF during the approval evaluation for pharmaceutical products. At the time of Thrombin 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 Thrombin suppliers with JDMF on PharmaCompass.
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