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    Chemistry

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    Also known as: Omeprazole magnesium, 95382-33-5, Magnesium;6-methoxy-2-[(4-methoxy-3,5-dimethylpyridin-2-yl)methylsulfinyl]-1h-benzimidazole
    Molecular Formula
    C34H38MgN6O6S2+2
    Molecular Weight
    715.1  g/mol
    InChI Key
    ZAUIQBMEUIXDRJ-UHFFFAOYSA-N
    Omeprazole Magnesium
    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.
    1 2D Structure

    Omeprazole Magnesium

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    magnesium;6-methoxy-2-[(4-methoxy-3,5-dimethylpyridin-2-yl)methylsulfinyl]-1H-benzimidazole
    2.1.2 InChI
    InChI=1S/2C17H19N3O3S.Mg/c2*1-10-8-18-15(11(2)16(10)23-4)9-24(21)17-19-13-6-5-12(22-3)7-14(13)20-17;/h2*5-8H,9H2,1-4H3,(H,19,20);/q;;+2
    2.1.3 InChI Key
    ZAUIQBMEUIXDRJ-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CC1=CN=C(C(=C1OC)C)CS(=O)C2=NC3=C(N2)C=C(C=C3)OC.CC1=CN=C(C(=C1OC)C)CS(=O)C2=NC3=C(N2)C=C(C=C3)OC.[Mg+2]
    2.2 Synonyms
    2.2.1 MeSH Synonyms

    1. H 168 68

    2. H 168-68

    3. H 16868

    4. Magnesium, Omeprazole

    5. Omeprazole

    6. Omeprazole Magnesium

    7. Omeprazole Sodium

    8. Prilosec

    9. Sodium, Omeprazole

    2.2.2 Depositor-Supplied Synonyms

    1. Omeprazole Magnesium

    2. 95382-33-5

    3. Magnesium;6-methoxy-2-[(4-methoxy-3,5-dimethylpyridin-2-yl)methylsulfinyl]-1h-benzimidazole

    2.3 Create Date
    2005-08-09
    3 Chemical and Physical Properties
    Molecular Weight 715.1 g/mol
    Molecular Formula C34H38MgN6O6S2+2
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count12
    Rotatable Bond Count10
    Exact Mass714.2144670 g/mol
    Monoisotopic Mass714.2144670 g/mol
    Topological Polar Surface Area193 Ų
    Heavy Atom Count49
    Formal Charge2
    Complexity453
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count2
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count3
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameOmeprazole magnesium
    Drug Label11 DESCRIPTIONThe active ingredient in PRILOSEC (omeprazole) Delayed-Release Capsules is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secret...
    Active IngredientOmeprazole magnesium
    Dosage FormCapsule, delayed release
    RouteOral
    Strengtheq 20mg base
    Market StatusOver the Counter
    CompanyDr Reddys Labs

    2 of 2  
    Drug NameOmeprazole magnesium
    Drug Label11 DESCRIPTIONThe active ingredient in PRILOSEC (omeprazole) Delayed-Release Capsules is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secret...
    Active IngredientOmeprazole magnesium
    Dosage FormCapsule, delayed release
    RouteOral
    Strengtheq 20mg base
    Market StatusOver the Counter
    CompanyDr Reddys Labs

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Proton Pump Inhibitors

    Compounds that inhibit H(+)-K(+)-EXCHANGING ATPASE. They are used as ANTI-ULCER AGENTS and sometimes in place of HISTAMINE H2 ANTAGONISTS for GASTROESOPHAGEAL REFLUX. (See all compounds classified as Proton Pump Inhibitors.)

    Anti-Ulcer Agents

    Various agents with different action mechanisms used to treat or ameliorate PEPTIC ULCER or irritation of the gastrointestinal tract. This has included ANTIBIOTICS to treat HELICOBACTER INFECTIONS; HISTAMINE H2 ANTAGONISTS to reduce GASTRIC ACID secretion; and ANTACIDS for symptomatic relief. (See all compounds classified as Anti-Ulcer Agents.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Proton Pump Inhibitor [EPC]; Proton Pump Inhibitors [MoA]; Cytochrome P450 2C19 Inhibitors [MoA]

    API Reference Price

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    02-Jan-2021
    31-Jan-2025
    KGS
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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 20...DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE

    USFDA APPLICATION NUMBER - 21229

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    DOSAGE - FOR SUSPENSION, DELAYED RELEASE;ORAL...DOSAGE - FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 10MG BASE/PACKET

    USFDA APPLICATION NUMBER - 22056

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    DOSAGE - FOR SUSPENSION, DELAYED RELEASE;ORAL...DOSAGE - FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 2.5MG BASE/PACKET

    USFDA APPLICATION NUMBER - 22056

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    ABOUT THIS PAGE

    Looking for 95382-33-5 / Omeprazole Magnesium API manufacturers, exporters & distributors?

    Omeprazole Magnesium manufacturers, exporters & distributors 1

    81

    PharmaCompass offers a list of Omeprazole Magnesium 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 Magnesium manufacturer or Omeprazole Magnesium supplier for your needs.

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

    PharmaCompass also assists you with knowing the Omeprazole Magnesium API Price utilized in the formulation of products. Omeprazole Magnesium API Price is not always fixed or binding as the Omeprazole Magnesium Price is obtained through a variety of data sources. The Omeprazole Magnesium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

    API | Excipient name

    Omeprazole Magnesium

    Synonyms

    95382-33-5, Magnesium;6-methoxy-2-[(4-methoxy-3,5-dimethylpyridin-2-yl)methylsulfinyl]-1h-benzimidazole

    Cas Number

    95382-33-5

    About Omeprazole Magnesium

    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 Magnesium Manufacturers

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

    Omeprazole Magnesium Suppliers

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

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

    Omeprazole Magnesium USDMF

    A Omeprazole Magnesium DMF (Drug Master File) is a document detailing the whole manufacturing process of Omeprazole Magnesium active pharmaceutical ingredient (API) in detail. Different forms of Omeprazole Magnesium DMFs exist exist since differing nations have different regulations, such as Omeprazole Magnesium USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A Omeprazole Magnesium DMF submitted to regulatory agencies in the US is known as a USDMF. Omeprazole Magnesium USDMF includes data on Omeprazole Magnesium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Omeprazole Magnesium USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of Omeprazole Magnesium suppliers with USDMF on PharmaCompass.

    Omeprazole Magnesium CEP

    A Omeprazole Magnesium CEP of the European Pharmacopoeia monograph is often referred to as a Omeprazole Magnesium Certificate of Suitability (COS). The purpose of a Omeprazole Magnesium CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Omeprazole Magnesium EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Omeprazole Magnesium to their clients by showing that a Omeprazole Magnesium CEP has been issued for it. The manufacturer submits a Omeprazole Magnesium CEP (COS) as part of the market authorization procedure, and it takes on the role of a Omeprazole Magnesium CEP holder for the record. Additionally, the data presented in the Omeprazole Magnesium CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Omeprazole Magnesium DMF.

    A Omeprazole Magnesium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Omeprazole Magnesium CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

    click here to find a list of Omeprazole Magnesium suppliers with CEP (COS) on PharmaCompass.

    Omeprazole Magnesium WC

    A Omeprazole Magnesium written confirmation (Omeprazole Magnesium WC) is an official document issued by a regulatory agency to a Omeprazole Magnesium manufacturer, verifying that the manufacturing facility of a Omeprazole Magnesium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Omeprazole Magnesium APIs or Omeprazole Magnesium finished pharmaceutical products to another nation, regulatory agencies frequently require a Omeprazole Magnesium WC (written confirmation) as part of the regulatory process.

    click here to find a list of Omeprazole Magnesium suppliers with Written Confirmation (WC) on PharmaCompass.

    Omeprazole Magnesium NDC

    National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Omeprazole Magnesium as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Omeprazole Magnesium API and other APIs are published in this directory by the FDA.

    Unfinished drugs

    The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

    Pharmaceutical companies that manufacture Omeprazole Magnesium as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

    Compounded drug products

    The NDC directory also contains data on finished compounded human drug products that contain Omeprazole Magnesium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Omeprazole Magnesium NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of Omeprazole Magnesium suppliers with NDC on PharmaCompass.

    Omeprazole Magnesium GMP

    Omeprazole Magnesium Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

    GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

    PharmaCompass offers a list of Omeprazole Magnesium GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Omeprazole Magnesium GMP manufacturer or Omeprazole Magnesium GMP API supplier for your needs.

    Omeprazole Magnesium CoA

    A Omeprazole Magnesium CoA (Certificate of Analysis) is a formal document that attests to Omeprazole Magnesium's compliance with Omeprazole Magnesium specifications and serves as a tool for batch-level quality control.

    Omeprazole Magnesium CoA mostly includes findings from lab analyses of a specific batch. For each Omeprazole Magnesium CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

    Omeprazole Magnesium may be tested according to a variety of international standards, such as European Pharmacopoeia (Omeprazole Magnesium EP), Omeprazole Magnesium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Omeprazole Magnesium USP).

    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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