Registration Number : 218MF10159
Registrant's Address : 1004-2 Hirakata, Koshigaya City, Saitama Prefecture
Initial Date of Registration : 2006-01-31
Latest Date of Registration : 2010-01-07
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PharmaCompass offers a list of 469-36-3 API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right 469-36-3 manufacturer or 469-36-3 supplier for your needs.
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PharmaCompass also assists you with knowing the 469-36-3 API Price utilized in the formulation of products. 469-36-3 API Price is not always fixed or binding as the 469-36-3 Price is obtained through a variety of data sources. The 469-36-3 Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A 469-36-3 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 469-36-3, including repackagers and relabelers. The FDA regulates 469-36-3 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 469-36-3 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 469-36-3 supplier is an individual or a company that provides 469-36-3 active pharmaceutical ingredient (API) or 469-36-3 finished formulations upon request. The 469-36-3 suppliers may include 469-36-3 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 469-36-3 Drug Master File in Japan (469-36-3 JDMF) empowers 469-36-3 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 469-36-3 JDMF during the approval evaluation for pharmaceutical products. At the time of 469-36-3 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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