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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PharmaCompass also assists you with knowing the Omeprazole Sodium API Price utilized in the formulation of products. Omeprazole Sodium API Price is not always fixed or binding as the Omeprazole Sodium Price is obtained through a variety of data sources. The Omeprazole Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Andra manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Andra, including repackagers and relabelers. The FDA regulates Andra manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Andra 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 Andra supplier is an individual or a company that provides Andra active pharmaceutical ingredient (API) or Andra finished formulations upon request. The Andra suppliers may include Andra API manufacturers, exporters, distributors and traders.
click here to find a list of Andra suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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 Andra Drug Master File in Japan (Andra JDMF) empowers Andra 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 Andra JDMF during the approval evaluation for pharmaceutical products. At the time of Andra 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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