01 1Hayashibara Co., Ltd.
01 1interferon-α "Hayashibara" HSA-free
01 1Japan
Interferon-α "Hayashibara" HSA-free
Registration Number : 217MF10026
Registrant's Address : 1-2-3 Shimoishii, Kita-ku, Okayama City
Initial Date of Registration : 2005-05-18
Latest Date of Registration : 2006-04-07
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PharmaCompass also assists you with knowing the Interferon Alfa-2B API Price utilized in the formulation of products. Interferon Alfa-2B API Price is not always fixed or binding as the Interferon Alfa-2B Price is obtained through a variety of data sources. The Interferon Alfa-2B Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A PEGINTRON manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of PEGINTRON, including repackagers and relabelers. The FDA regulates PEGINTRON manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. PEGINTRON API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A PEGINTRON supplier is an individual or a company that provides PEGINTRON active pharmaceutical ingredient (API) or PEGINTRON finished formulations upon request. The PEGINTRON suppliers may include PEGINTRON 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 PEGINTRON Drug Master File in Japan (PEGINTRON JDMF) empowers PEGINTRON 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 PEGINTRON JDMF during the approval evaluation for pharmaceutical products. At the time of PEGINTRON 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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