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

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    Ivacaftor

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    01 AR Life Sciences (1)

    02 Alembic Pharmaceuticals Limited (1)

    03 Aurobindo Pharma Limited (2)

    04 Glenmark Life Sciences (1)

    05 Lupin Ltd (1)

    06 MSN Laboratories (1)

    07 ScinoPharm Taiwan, Ltd (1)

    08 Sun Pharmaceutical Industries Limited (1)

    09 Vindhya Organics (2)

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    01 4-OXO-1,4-DIHYDROQUINOLINE-3-CARBOXYLIC ACID [STARTING MATERIAL OF IVACAFTOR] (1)

    02 4-OXO-1,4-DIHYDROQUINOLINE-3-CARBOXYLIC ACID/IVF-3P (1)

    03 AMINO PHENOL DERIVATIVE [STARTING MATERIAL OF IVACATOR] (1)

    04 IVACAFTOR (6)

    05 IVACAFTOR PREMIX (1)

    06 IVACAFTOR [ROUTE CODE - 'IC'] (1)

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    ALEMBIC PHARMACEUTICALS LTD

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    IVACAFTOR

    PDF Supplier PDF
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    31849
    Active
    2017-06-30
    Complete
    2017-07-18
    2017-06-28
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    AR LIFE SCIENCES PVT LTD

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      4-OXO-1,4-DIHYDROQUINOLINE-3-CARBOXYLIC ACID/IVF-3P

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      35586
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      2021-02-11
      N/A
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      APITORIA PHARMA PRIVATE LTD

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      IVACAFTOR

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      36094
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      2021-07-07
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      2021-08-13
      2021-07-07
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      GLENMARK LIFE SCIENCES LTD

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        IVACAFTOR

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        28867
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        2015-03-10
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        2015-05-19
        2015-03-10
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        LUPIN MANUFACTURING SOLUTIONS LIMIT...

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        IVACAFTOR

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        32610
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        2019-03-29
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        2020-08-20
        2020-07-02
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        MSN LABORATORIES PRIVATE LTD

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        IVACAFTOR [ROUTE CODE - 'IC']

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        29398
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        2015-05-30
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        2023-10-17
        2023-08-29
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        SCINOPHARM TAIWAN LTD

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        IVACAFTOR

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        35447
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        2020-12-28
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        SUN PHARMACEUTICAL INDUSTRIES LTD

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        IVACAFTOR

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        33783
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        2019-07-26
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        2019-09-10
        2019-07-25
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        VINDHYA ORGANICS PRIVATE LTD

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          4-OXO-1,4-DIHYDROQUINOLINE-3-CARBOXYLIC ACID [STARTING MATERIAL OF IVACAFTOR]

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          35587
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          2021-02-09
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          VINDHYA ORGANICS PRIVATE LTD

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            AMINO PHENOL DERIVATIVE [STARTING MATERIAL OF IVACATOR]

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            35551
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            2021-01-25
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            Looking for 873054-44-5 / Ivacaftor API manufacturers, exporters & distributors?

            Ivacaftor manufacturers, exporters & distributors 1

            23

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

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

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

            API | Excipient name

            Ivacaftor

            Synonyms

            873054-44-5, Vx-770, Kalydeco, Ivacaftor (vx-770), N-(2,4-di-tert-butyl-5-hydroxyphenyl)-4-oxo-1,4-dihydroquinoline-3-carboxamide, Vx 770

            Cas Number

            873054-44-5

            Unique Ingredient Identifier (UNII)

            1Y740ILL1Z

            About Ivacaftor

            Ivacaftor (also known as Kalydeco or VX-770) is a drug used for the management of Cystic Fibrosis (CF). It is manufactured and distributed by Vertex Pharmaceuticals. It was approved by the Food and Drug Administration on January 31, 2012, and by Health Canada in late 2012. Ivacaftor is administered as a monotherapy and also administered in combination with other drugs for the management of CF. Cystic Fibrosis is an autosomal recessive disorder caused by one of several different mutations in the gene for the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) protein, an ion channel involved in the transport of chloride and sodium ions across cell membranes. CFTR is active in epithelial cells of organs such as of the lungs, pancreas, liver, digestive system, and reproductive tract. Alterations in the CFTR gene result in altered production, misfolding, or function of the protein and consequently abnormal fluid and ion transport across cell membranes. As a result, CF patients produce thick, sticky mucus that clogs the ducts of organs where it is produced making patients more susceptible to complications such as infections, lung damage, pancreatic insufficiency, and malnutrition. Prior to the development of ivacaftor, management of CF primarily involved therapies for the control of infections, nutritional support, clearance of mucus, and management of symptoms rather than improvements in the underlying disease process or lung function (FEV1). Notably, ivacaftor was the first medication approved for the management of the underlying causes of CF (abnormalities in CFTR protein function) rather than control of symptoms.

            Ivacaftor Manufacturers

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

            Ivacaftor Suppliers

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

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

            Ivacaftor USDMF

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

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

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

            Ivacaftor Manufacturers | Traders | Suppliers

            Ivacaftor Manufacturers, Traders, Suppliers 1
            72

            We have 9 companies offering Ivacaftor

            Get in contact with the supplier of your choice:

            1. Alembic Pharmaceuticals Limited
            2. AR Life Sciences
            3. Aurobindo Pharma Limited
            4. Glenmark Life Sciences
            5. Lupin Ltd
            6. MSN Laboratories
            7. ScinoPharm Taiwan, Ltd
            8. Sun Pharmaceutical Industries Limited
            9. Vindhya Organics
            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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