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    List of Drug Master Files (KDMF) for Harvoni Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

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    Harvoni

    APIs // Active Pharmaceutical Ingredients

    PRICE INFORMATION

    INTERMEDIATES

    DOSSIERs // Finished Dosage Forms

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    Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

    ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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    01 Esteve Quimica, S.A. (1)

    02 Yuhan Chemical (1)

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    01 Gilead Sciences Korea Ltd. (2)

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    01 Ledipasvir (2)

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    01 South Korea (1)

    02 Spain (1)

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    Esteve Quimica

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    Ledipasvir

    PDF Supplier PDF
    URL Supplier Web Content
    Gilead Sciences Korea Ltd.
    2015-10-12
    Number 6273-5-ND
    Esteve Quimica, S.A.
    Spain
    C/ Ter, 94 Polígon Indus...
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    Yuhan Corporation

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    Ledipasvir

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    URL Supplier Web Content
    Gilead Sciences Korea Ltd.
    2015-08-26
    Number 6273-3-ND
    Yuhan Chemical
    South Korea
    45 Jiwon-ro, Danwon-gu, A...
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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).

    Harvoni Manufacturers

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

    Harvoni Suppliers

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

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

    Harvoni KDMF

    In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

    Pharmaceutical companies submit a Harvoni Drug Master File in Korea (Harvoni KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Harvoni. The MFDS reviews the Harvoni KDMF as part of the drug registration process and uses the information provided in the Harvoni KDMF to evaluate the safety and efficacy of the drug.

    After submitting a Harvoni KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Harvoni API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Harvoni suppliers with KDMF on PharmaCompass.

    Harvoni Manufacturers | Traders | Suppliers

    Harvoni Manufacturers, Traders, Suppliers 1
    94

    We have 2 companies offering Harvoni

    Get in contact with the supplier of your choice:

    1. Esteve Quimica
    2. Yuhan Corporation
    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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