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

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    Glecaprevir

    APIs // Active Pharmaceutical Ingredients

    DEVELOPMENTS

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    INTERMEDIATES

    DOSSIERs // Finished Dosage Forms

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    01 [Manufacture of Intermediate 3 and API] AbbVie Srl@[Manufacture of Intermediate L and Intermediate 2] Jilin Asymchem Laboratories Co., Ltd@[Manufacture of Intermediate 1] Lundbeck Pharmaceuticals Italy SpA (1)

    02 [Manufacture of Intermediate 3 and API] Abbvie Ireland NL BV@[Manufacture of Intermediate 1] Lundbeck Pharmaceuticals Italy SpA@[Manufacture of Intermediate L and Intermediate 2] Jilin Asymchem Laboratories Co., Ltd (1)

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    01 AbbVie Korea Co., Ltd. (2)

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    01 glecaprevir (2)

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    01 U.S.A (2)

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    AbbVie Inc

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    glecaprevir

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    AbbVie Korea Co., Ltd.
    2018-06-27
    Number 325-9-ND
    [Manufacture of Intermedi...
    U.S.A
    [Manufacture of Intermedi...
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    RDD 2024

    Not Confirmed

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    AbbVie Inc

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    glecaprevir

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    AbbVie Korea Co., Ltd.
    2017-12-15
    Number 325-7-ND
    [Manufacture of Intermedi...
    U.S.A
    Manorhamilton Road, Sligo...
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    RDD 2024

    Not Confirmed

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    Looking for 1365970-03-1 / Glecaprevir API manufacturers, exporters & distributors?

    Glecaprevir manufacturers, exporters & distributors 1

    53

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

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

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

    API | Excipient name

    Glecaprevir

    Synonyms

    Abt-493, Glecaprevir [usan], 1365970-03-1, A-1282576.0, K6buu8j72p, A-1282576

    Cas Number

    1365970-03-1

    Unique Ingredient Identifier (UNII)

    K6BUU8J72P

    About Glecaprevir

    Glecaprevir is a direct acting antiviral agent and Hepatitis C virus (HCV) NS3/4A protease inhibitor that targets the the viral RNA replication. In combination with [DB13878], glecaprevir is a useful therapy for patients who experienced therapeutic failure from other NS3/4A protease inhibitors. It demonstrates a high genetic barrier against resistance mutations of the virus. In cell cultures, the emergence of amino acid substitutions at NS3 resistance-associated positions A156 or D/Q168 in HCV genotype 1a, 2a or 3a replicons led to reduced susceptibility to glecaprevir. The combinations of amino acid substitutions at NS3 position Y65H and D/Q168 also results in greater reductions in glecaprevir susceptibility, and NS3 Q80R in genotype 3a patients also leads to glecaprevir resistance. Glecaprevir is available as an oral combination therapy with [DB13878] under the brand name Mavyret. This fixed-dose combination therapy was FDA-approved in August 2017 to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis, including patients with moderate to severe kidney disease and those who are on dialysis. Mavyret is also indicated for HCV genotype 1-infected patients who have been previously treated with regimens either containing an NS5A inhibitor or an NS3/4A protease inhibitor, but not both. Hepatitis C viral infection often leads to decreased liver function and subsequent liver failure, causing a significantly negative impact on the patients' quality of life. The ultimate goal of the combination treatment is to achieve sustained virologic response (SVR) and cure the patients from the infection. In clinical trials, this combination therapy achieved SVR12 rate, or undetectable Hepatitis C for twelve or more weeks after the end of treatment, of 93% across genotypes 1a, 2a, 3a, 4, 5 and 6.

    Glecaprevir Manufacturers

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

    Glecaprevir Suppliers

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

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

    Glecaprevir KDMF

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

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

    After submitting a Glecaprevir 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 Glecaprevir API can apply through the Korea Drug Master File (KDMF).

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

    Glecaprevir Manufacturers | Traders | Suppliers

    Glecaprevir Manufacturers, Traders, Suppliers 1
    10

    We have 1 companies offering Glecaprevir

    Get in contact with the supplier of your choice:

    1. AbbVie Inc
    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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