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

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    Ledipasvir

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    01 Fuxin Long Rui Pharmaceutical (1)

    02 Lupin Ltd (1)

    03 Viatris (1)

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    01 LEDIPASVIR (2)

    02 LEDIPASVIR: PVP (1:1) (1)

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    01 China (1)

    02 India (1)

    03 U.S.A (1)

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    FUXIN LONG RUI PHARMACEUTICAL CO LT...

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      LEDIPASVIR: PVP (1:1)

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      33491
      Active
      2019-07-09
      N/A
      II
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      LUPIN LTD

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      LEDIPASVIR

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      34446
      Inactive
      2019-12-31
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      MYLAN LABORATORIES LTD

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      LEDIPASVIR

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      33430
      Active
      2018-12-28
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      Looking for 1256388-51-8 / Ledipasvir API manufacturers, exporters & distributors?

      Ledipasvir manufacturers, exporters & distributors 1

      77

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

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

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

      API | Excipient name

      Ledipasvir

      Synonyms

      1256388-51-8, Gs-5885, Gs5885, Ledipasvir acetonate, Gs 5885, Ledipasvir [usan]

      Cas Number

      1256388-51-8

      Unique Ingredient Identifier (UNII)

      013TE6E4WV

      About Ledipasvir

      Ledipasvir is an orally available inhibitor of the hepatitis C virus (HCV) non-structural protein 5A (NS5A) replication complex, with potential activity against HCV. Upon oral administration and after intracellular uptake, ledipasvir binds to and blocks the activity of the NS5A protein. This results in the disruption of the viral RNA replication complex, blockage of HCV RNA production, and inhibition of viral replication. NS5A, a zinc-binding and proline-rich hydrophilic phosphoprotein, plays a crucial role in HCV RNA replication. HCV is a small, enveloped, single-stranded RNA virus belonging to the Flaviviridae family; HCV infection is associated with the development of hepatocellular carcinoma (HCC).

      Ledipasvir Manufacturers

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

      Ledipasvir Suppliers

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

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

      Ledipasvir USDMF

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

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

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

      Ledipasvir Manufacturers | Traders | Suppliers

      Ledipasvir Manufacturers, Traders, Suppliers 1
      97

      We have 3 companies offering Ledipasvir

      Get in contact with the supplier of your choice:

      1. Fuxin Long Rui Pharmaceutical
      2. Lupin Ltd
      3. Viatris
      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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