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    List of Written Confirmation(s) issued for Kalydeco Active Pharmaceutical Ingredient (API)

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    01 M/s Glenmark Life Sciences Limited (1)

    02 M/s. Alembic Pharmaceuticals Limited (1)

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    01 Ivacaftor IH (2)

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    01 WC-0057n (1)

    02 WC-0082 (1)

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    Alembic Pharmaceuticals Limited

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    Ivacaftor IH

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    WC-0082
    API Division Kharakhadi, Plot No. 842-843, Kharakhadi, Padra Vadodara-391 450, Gujarat India
    2025-07-02
    2022-06-17
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    Glenmark Life Sciences

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      Ivacaftor IH

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      WC-0057n
      Plot No. 3109, GIDC, Industrial Estate, Ankleshwar-393 002, Bharuch, Gujarat
      2025-06-25
      2022-06-07
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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.

      Kalydeco Manufacturers

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

      Kalydeco Suppliers

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

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

      Kalydeco WC

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

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

      Kalydeco Manufacturers | Traders | Suppliers

      Kalydeco Manufacturers, Traders, Suppliers 1
      81

      We have 2 companies offering Kalydeco

      Get in contact with the supplier of your choice:

      1. Alembic Pharmaceuticals Limited
      2. Glenmark Life Sciences
      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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