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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A Laki Lorand Factor manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Laki Lorand Factor, including repackagers and relabelers. The FDA regulates Laki Lorand Factor manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Laki Lorand Factor 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 Laki Lorand Factor supplier is an individual or a company that provides Laki Lorand Factor active pharmaceutical ingredient (API) or Laki Lorand Factor finished formulations upon request. The Laki Lorand Factor suppliers may include Laki Lorand Factor 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 Laki Lorand Factor Drug Master File in Japan (Laki Lorand Factor JDMF) empowers Laki Lorand Factor 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 Laki Lorand Factor JDMF during the approval evaluation for pharmaceutical products. At the time of Laki Lorand Factor 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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