01 1Excella GmbH & Co. K.G.
01 1Deferoxamine mesylate
01 1Luxembourg
Registration Number : 223MF10158
Registrant's Address : NUERNBERGER STRASSE 12, 90537 FEUCHT, GERMANY
Initial Date of Registration : 2011-11-14
Latest Date of Registration : 2011-11-14
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PharmaCompass also assists you with knowing the Deferoxamine Mesylate API Price utilized in the formulation of products. Deferoxamine Mesylate API Price is not always fixed or binding as the Deferoxamine Mesylate Price is obtained through a variety of data sources. The Deferoxamine Mesylate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A D9533_SIGMA manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of D9533_SIGMA, including repackagers and relabelers. The FDA regulates D9533_SIGMA manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. D9533_SIGMA 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 D9533_SIGMA supplier is an individual or a company that provides D9533_SIGMA active pharmaceutical ingredient (API) or D9533_SIGMA finished formulations upon request. The D9533_SIGMA suppliers may include D9533_SIGMA 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 D9533_SIGMA Drug Master File in Japan (D9533_SIGMA JDMF) empowers D9533_SIGMA 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 D9533_SIGMA JDMF during the approval evaluation for pharmaceutical products. At the time of D9533_SIGMA 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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