01 1Esteve Quimica, S. A.
01 1Omeprazole sodium (production only)
01 1Spain
Omeprazole sodium (for manufacturing purposes only)
Registration Number : 221MF10170
Registrant's Address : Torre Esteve, Pg. de la Zona Franca, 109, 4th floor, 08038 Barcelona - Spain
Initial Date of Registration : 2009-07-30
Latest Date of Registration : 2011-10-14
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PharmaCompass offers a list of Omeprazole Sodium 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 Omeprazole Sodium manufacturer or Omeprazole Sodium supplier for your needs.
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A Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam, including repackagers and relabelers. The FDA regulates Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam 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 Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam supplier is an individual or a company that provides Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam active pharmaceutical ingredient (API) or Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam finished formulations upon request. The Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam suppliers may include Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam 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 Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam Drug Master File in Japan (Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam JDMF) empowers Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam 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 Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam JDMF during the approval evaluation for pharmaceutical products. At the time of Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam 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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We have 1 companies offering Esomeprazole sodium, Nexium I.V., Sompraz, Zoleri, Lucen, Esopral, Axagon, Nexiam
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