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    List of Drug Master Files (DMF) of Lumacaftor Active Pharmaceutical Ingredient listed on PharmaCompass.com

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    Lumacaftor

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    MAITHRI DRUGS PRIVATE LTD

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      LUMACAFTOR

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      Looking for 936727-05-8 / Lumacaftor API manufacturers, exporters & distributors?

      Lumacaftor manufacturers, exporters & distributors 1

      42

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

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

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

      API | Excipient name

      Lumacaftor

      Synonyms

      936727-05-8, Vx-809, Vx 809, Vx809, Vrt-826809, 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid

      Cas Number

      936727-05-8

      Unique Ingredient Identifier (UNII)

      EGP8L81APK

      About Lumacaftor

      Lumacaftor is a drug used in combination with [DB08820] as the fixed dose combination product Orkambi for the management of Cystic Fibrosis (CF) in patients aged 6 years and older. 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, a transmembrane ion channel involved in the transport of chloride and sodium ions across cell membranes of the lungs, pancreas, and other organs. Mutations in the CFTR gene result in altered production, misfolding, or function of the CFTR 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 infections, lung damage, pancreatic insufficiency, and malnutrition. Lumacaftor improves CF symptoms and underlying disease pathology by aiding the conformational stability of F508del-mutated CFTR proteins, preventing misfolding and resulting in increased processing and trafficking of mature protein to the cell surface. Results from clinical trials indicated that treatment with Orkambi (lumacaftor/ivacaftor) results in improved lung function, reduced chance of experiencing a pulmonary exacerbation, increased weight gain, and improvements in CF symptoms. This data has been heavily scrutinized, however, with clinical trials showing only modest improvements despite a hefty yearly cost of $259,000 for Orkambi. Improvements in lung function (ppFEV1) were found to be statistically significant, but minimal, with only a 2.6-3.0% change from baseline with more than 70% of patients failing to achieve an absolute improvement of at least 5%. A wide variety of CFTR mutations correlate to the Cystic Fibrosis phenotype and are associated with differing levels of disease severity. The most common mutation, affecting approximately 70% of patients with CF worldwide, is known as F508del-CFTR, or delta-F508 (F508), in which a deletion in the amino acid phenylalanine at position 508 results in impaired production of the CFTR protein, thereby causing a significant reduction in the amount of ion transporter present on cell membranes. When used in combination with [DB08820] as the fixed dose combination product Orkambi, lumacaftor is specific for the management of CF in patients with delta-F508 mutations as it acts as a protein-folding chaperone, aiding the conformational stability of the mutated CFTR protein. Consequently, lumacaftor increases successful production of CFTR ion channels and the total number of receptors available for use at the cell membrane for fluid and ion transport. The next most common mutation, G551D, affecting 4-5% of CF patients worldwide, is characterized as a missense mutation, whereby there is sufficient amount of protein at the cell surface, but opening and closing mechanisms of the channel are altered. Treatment of patients with G551D and other rarer missense mutations is usually managed with [DB08820] (Kalydeco), as it aids with altered gating mechanisms by potentiating channel opening probability of CFTR protein. Prior to the development of lumacaftor and [DB08820] (Kalydeco), 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. Approved for use by the Food and Drug Administration in July 2015 and by Health Canada in January 2016, Orkambi was the first combination product approved for the management of Cystic Fibrosis with delta-F508 mutations. Ivacaftor is manufactured and distributed by Vertex Pharmaceuticals.

      Lumacaftor Manufacturers

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

      Lumacaftor Suppliers

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

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

      Lumacaftor USDMF

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

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

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

      Lumacaftor Manufacturers | Traders | Suppliers

      Lumacaftor Manufacturers, Traders, Suppliers 1
      20

      We have 1 companies offering Lumacaftor

      Get in contact with the supplier of your choice:

      1. Maithri Drugs
      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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