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01 1Hayashibara Co., Ltd.
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01 1interferon-α "Hayashibara" HSA-free
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01 1Japan
Interferon-α "Hayashibara" HSA-free
Registration Number : 217MF10026
Registrant's Address : Okayama City, Kita Ward, Shimoishii 1-2-3
Initial Date of Registration : 2005-05-18
Latest Date of Registration : 2006-04-07
A Interferon Alfa-2B manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Interferon Alfa-2B, including repackagers and relabelers. The FDA regulates Interferon Alfa-2B manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Interferon Alfa-2B API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Interferon Alfa-2B manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Interferon Alfa-2B supplier is an individual or a company that provides Interferon Alfa-2B active pharmaceutical ingredient (API) or Interferon Alfa-2B finished formulations upon request. The Interferon Alfa-2B suppliers may include Interferon Alfa-2B API manufacturers, exporters, distributors and traders.
click here to find a list of Interferon Alfa-2B 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 Interferon Alfa-2B Drug Master File in Japan (Interferon Alfa-2B JDMF) empowers Interferon Alfa-2B 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 Interferon Alfa-2B JDMF during the approval evaluation for pharmaceutical products. At the time of Interferon Alfa-2B 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 Interferon Alfa-2B suppliers with JDMF on PharmaCompass.
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