01 1Esteve Quimica, S. A.
01 1Omeprazole sodium (production only)
01 1Spain
Omeprazole Sodium (for manufacturing 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
A Omeprazole Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Omeprazole Sodium, including repackagers and relabelers. The FDA regulates Omeprazole Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Omeprazole Sodium API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Omeprazole Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Omeprazole Sodium supplier is an individual or a company that provides Omeprazole Sodium active pharmaceutical ingredient (API) or Omeprazole Sodium finished formulations upon request. The Omeprazole Sodium suppliers may include Omeprazole Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Omeprazole Sodium 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 Omeprazole Sodium Drug Master File in Japan (Omeprazole Sodium JDMF) empowers Omeprazole Sodium 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 Omeprazole Sodium JDMF during the approval evaluation for pharmaceutical products. At the time of Omeprazole Sodium JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Omeprazole Sodium suppliers with JDMF on PharmaCompass.
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