01 1Heraeus Precious Metals GmbH & Co. K.G.
01 1Arsenic trioxide
01 1Germany
Registration Number : 224MF10077
Registrant's Address : Heraeusstr. 12-14;63450 Hanau;Germany
Initial Date of Registration : 2012-04-08
Latest Date of Registration : 2014-09-30
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PharmaCompass offers a list of Arsenic Trioxide 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 Arsenic Trioxide manufacturer or Arsenic Trioxide supplier for your needs.
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PharmaCompass also assists you with knowing the Arsenic Trioxide API Price utilized in the formulation of products. Arsenic Trioxide API Price is not always fixed or binding as the Arsenic Trioxide Price is obtained through a variety of data sources. The Arsenic Trioxide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A TRISENOX manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of TRISENOX, including repackagers and relabelers. The FDA regulates TRISENOX manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. TRISENOX 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 TRISENOX supplier is an individual or a company that provides TRISENOX active pharmaceutical ingredient (API) or TRISENOX finished formulations upon request. The TRISENOX suppliers may include TRISENOX 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 TRISENOX Drug Master File in Japan (TRISENOX JDMF) empowers TRISENOX 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 TRISENOX JDMF during the approval evaluation for pharmaceutical products. At the time of TRISENOX 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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