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    List of Drug Master Files (JDMF) for Omeprazole Sodium Hydrate Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Japan (PMDA). Original Data : PMDA Database

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    Omeprazole Sodium Hydrate

    APIs // Active Pharmaceutical Ingredients

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    01 Esteve Quimica, S. A. (1)

    02 Guilin Hwasun Pharmaceutical Co. , Ltd. (1)

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    01 Omeprazole Sodium (1)

    02 Omeprazole sodium (production only) (1)

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    01 China (1)

    02 Spain (1)

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    Guilin Hwasun Pharmaceutical Co. , ...

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      Omeprazole sodium

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      231MF10071
      No. 89, 1st street, Lingbei Road, L...
      2019-03-12
      2019-03-12
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      Esteve Quimica, S. A.

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      • EDQM
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      Omeprazole sodium (for manufacturing only)

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      221MF10170
      Torre Esteve, Pg. de la Zona Franca...
      2011-10-14
      2009-07-30
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      Looking for 95510-70-6 / Omeprazole Sodium API manufacturers, exporters & distributors?

      Omeprazole Sodium manufacturers, exporters & distributors 1

      51

      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.

      Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Omeprazole Sodium manufacturer or Omeprazole Sodium supplier.

      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.

      API | Excipient name

      Omeprazole Sodium

      Synonyms

      Losec sodium, H 168/68 sodium, 95510-70-6, Omeprazole sodium [usan], 161796-78-7, Omeprazole (as sodium)

      Cas Number

      95510-70-6

      Unique Ingredient Identifier (UNII)

      KV03YZ6QLW

      About Omeprazole Sodium

      A 4-methoxy-3,5-dimethylpyridyl, 5-methoxybenzimidazole derivative of timoprazole that is used in the therapy of STOMACH ULCERS and ZOLLINGER-ELLISON SYNDROME. The drug inhibits an H(+)-K(+)-EXCHANGING ATPASE which is found in GASTRIC PARIETAL CELLS.

      Omeprazole Sodium Hydrate Manufacturers

      A Omeprazole Sodium Hydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Omeprazole Sodium Hydrate, including repackagers and relabelers. The FDA regulates Omeprazole Sodium Hydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Omeprazole Sodium Hydrate 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 Hydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

      Omeprazole Sodium Hydrate Suppliers

      A Omeprazole Sodium Hydrate supplier is an individual or a company that provides Omeprazole Sodium Hydrate active pharmaceutical ingredient (API) or Omeprazole Sodium Hydrate finished formulations upon request. The Omeprazole Sodium Hydrate suppliers may include Omeprazole Sodium Hydrate API manufacturers, exporters, distributors and traders.

      click here to find a list of Omeprazole Sodium Hydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

      Omeprazole Sodium Hydrate JDMF

      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 Hydrate Drug Master File in Japan (Omeprazole Sodium Hydrate JDMF) empowers Omeprazole Sodium Hydrate 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 Hydrate JDMF during the approval evaluation for pharmaceutical products. At the time of Omeprazole Sodium Hydrate 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 Hydrate suppliers with JDMF on PharmaCompass.

      Omeprazole Sodium Hydrate Manufacturers | Traders | Suppliers

      Omeprazole Sodium Hydrate Manufacturers, Traders, Suppliers 1
      13

      We have 2 companies offering Omeprazole Sodium Hydrate

      Get in contact with the supplier of your choice:

      1. Guilin Hwasun Pharmaceutical
      2. UQUIFA
      Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
      For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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