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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 PEGINTERFERON ALFA-2B manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of PEGINTERFERON ALFA-2B, including repackagers and relabelers. The FDA regulates PEGINTERFERON ALFA-2B manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. PEGINTERFERON 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 PEGINTERFERON ALFA-2B manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A PEGINTERFERON ALFA-2B supplier is an individual or a company that provides PEGINTERFERON ALFA-2B active pharmaceutical ingredient (API) or PEGINTERFERON ALFA-2B finished formulations upon request. The PEGINTERFERON ALFA-2B suppliers may include PEGINTERFERON ALFA-2B API manufacturers, exporters, distributors and traders.
click here to find a list of PEGINTERFERON 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 PEGINTERFERON ALFA-2B Drug Master File in Japan (PEGINTERFERON ALFA-2B JDMF) empowers PEGINTERFERON 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 PEGINTERFERON ALFA-2B JDMF during the approval evaluation for pharmaceutical products. At the time of PEGINTERFERON 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 PEGINTERFERON ALFA-2B suppliers with JDMF on PharmaCompass.
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