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    List of Drug Master Files (DMF) of Isosorbide Mononitrate Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Isosorbide Mononitrate

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    01 Cambrex Corporation (1)

    02 DOTTIKON EXCLUSIVE SYNTHESIS AG (1)

    03 Dipharma (1)

    04 Kremers Urban Pharmaceuticals Inc. (1)

    05 Lunan Pharmaceutical (4)

    06 NORDIC SYNTHESIS AB (1)

    07 Shandong Keyuan Pharmaceutical Co., Ltd. (1)

    08 Blank (2)

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    01 DILUTED ISOSORBIDE MONONITRATE (1)

    02 DILUTED ISOSORBIDE MONONITRATE (60%) (1)

    03 DILUTED ISOSORBIDE MONONITRATE (70%) (1)

    04 DILUTED ISOSORBIDE MONONITRATE (DRUG SUBSTANCE, NON-STERILE) (1)

    05 DILUTED ISOSORBIDE MONONITRATE USP (1)

    06 ISOSORBIDE 5-MONONITRATE (5-ISM) (1)

    07 ISOSORBIDE MONONITRATE (NON-STERILE, BULK FORM) (1)

    08 ISOSORBIDE-2-MONONITRATE (1)

    09 ISOSORBIDE-2-MONONITRATE (2-ISMN) (1)

    10 ISOSORBIDE-5-MONONITRATE (1)

    11 ISOSORBIDE-5-MONONITRATE (5-ISMN) (1)

    12 ISOSORBIDE-5-MONONITRATE/LACTOSE (1)

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    01 China (5)

    02 Italy (1)

    03 Sweden (1)

    04 Switzerland (1)

    05 U.S.A (2)

    06 Blank (2)

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    01 Active (5)

    02 Inactive (7)

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    01 Complete (3)

    02 Blank (9)

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    CAMBREX KARLSKOGA AB

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    • EDQM
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    ISOSORBIDE-5-MONONITRATE/LACTOSE

    PDF Supplier PDF
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    12679
    Inactive
    1997-10-02
    N/A
    II
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    DIPHARMA FRANCIS SRL

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    ISOSORBIDE-5-MONONITRATE (5-ISMN)

    PDF Supplier PDF
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    6778
    Active
    1987-01-09
    Complete
    2013-01-15
    2012-12-24
    II
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    DOTTIKON EXCLUSIVE SYNTHESIS AG

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    DILUTED ISOSORBIDE MONONITRATE

    PDF Supplier PDF
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    6789
    Inactive
    1987-01-23
    N/A
    II
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    EIRCHEM PHARMA SERVICES LTD

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    ISOSORBIDE 5-MONONITRATE (5-ISM)

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    6362
    Active
    1984-10-04
    N/A
    II
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    SHANDONG NEW TIME PHARMACEUTICAL CO...

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      DILUTED ISOSORBIDE MONONITRATE (70%)

      PDF Supplier PDF
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      23217
      Active
      2009-10-21
      N/A
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      SHANDONG NEW TIME PHARMACEUTICAL CO...

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        DILUTED ISOSORBIDE MONONITRATE (60%)

        PDF Supplier PDF
        URL Supplier Web Content
        23216
        Active
        2009-10-21
        Complete
        2014-04-28
        2013-12-24
        II
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        SHANDONG NEW TIME PHARMACEUTICAL CO...

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          DILUTED ISOSORBIDE MONONITRATE USP

          PDF Supplier PDF
          URL Supplier Web Content
          29555
          Active
          2015-07-17
          Complete
          2019-01-22
          2018-11-26
          II
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          NORDIC SYNTHESIS AB

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            ISOSORBIDE-5-MONONITRATE

            PDF Supplier PDF
            URL Supplier Web Content
            5607
            Inactive
            1984-11-15
            N/A
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            GRAESSER LABORATORIES LTD

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            ISOSORBIDE-2-MONONITRATE

            PDF Supplier PDF
            URL Supplier Web Content
            6803
            Inactive
            1987-02-05
            N/A
            II
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            DINAMITE DIPHARMA SPA

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            ISOSORBIDE-2-MONONITRATE (2-ISMN)

            PDF Supplier PDF
            URL Supplier Web Content
            6777
            Inactive
            1987-01-09
            N/A
            II
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            Looking for 16051-77-7 / Isosorbide Mononitrate API manufacturers, exporters & distributors?

            Isosorbide Mononitrate manufacturers, exporters & distributors 1

            26

            PharmaCompass offers a list of Isosorbide Mononitrate 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 Isosorbide Mononitrate manufacturer or Isosorbide Mononitrate supplier for your needs.

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

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

            API | Excipient name

            Isosorbide Mononitrate

            Synonyms

            Isosorbide 5-mononitrate, 16051-77-7, Imdur, Corangin, Monosorbitrate, Monoket

            Cas Number

            16051-77-7

            Unique Ingredient Identifier (UNII)

            LX1OH63030

            About Isosorbide Mononitrate

            Isosorbide Mononitrate is the mononitrate salt form of isosorbide, an organic nitrate with vasodilator activity. Isosorbide mononitrate relaxes vascular smooth muscle by formation of the free radical nitric oxide (NO), which is identical to the endothelium-derived relaxing factor (EDRF). NO activates guanylyl cyclase, thereby increasing the synthesis of cGMP within smooth muscle, resulting in dephosphorylation of light chain myosin and relaxation of peripheral arteries and veins. In addition, isosorbide mononitrate relaxes coronary arteries, thereby increasing the blood circulation through the ischemic area. (NCI05)

            Isosorbide Mononitrate Manufacturers

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

            Isosorbide Mononitrate Suppliers

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

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

            Isosorbide Mononitrate USDMF

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

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

            click here to find a list of Isosorbide Mononitrate suppliers with USDMF on PharmaCompass.

            Isosorbide Mononitrate Manufacturers | Traders | Suppliers

            Isosorbide Mononitrate Manufacturers, Traders, Suppliers 1
            35

            We have 7 companies offering Isosorbide Mononitrate

            Get in contact with the supplier of your choice:

            1. Cambrex Corporation
            2. Dipharma
            3. DOTTIKON EXCLUSIVE SYNTHESIS AG
            4. Kremers Urban Pharmaceuticals Inc.
            5. Lunan Pharmaceutical
            6. NORDIC SYNTHESIS AB
            7. Shandong Keyuan Pharmaceutical Co., Ltd.
            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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