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

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    Clevudine

    APIs // Active Pharmaceutical Ingredients

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    Pharmacostech

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      Clevudine

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      Pharmacotech Co., Ltd.
      2016-09-12
      20160912-202-I-505-02
      Pharmacotech Co., Ltd.
      South Korea
      47, Jaekdanji-ro, Hyangna...
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      Looking for 163252-36-6 / Clevudine API manufacturers, exporters & distributors?

      Clevudine manufacturers, exporters & distributors 1

      14

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

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

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

      API | Excipient name

      Clevudine

      Synonyms

      163252-36-6, L-fmau, Levovir, Clevudine (levovir), In51mvp5f1, 1-(2-deoxy-2-fluoro-beta-l-arabinofuranosyl)thymine

      Cas Number

      163252-36-6

      Unique Ingredient Identifier (UNII)

      IN51MVP5F1

      About Clevudine

      Clevudine is a synthetic pyrimidine analogue with activity against hepatitis B virus (HBV). Intracellularly, clevudine is phosphorylated to its active metabolites, clevudine monophosphate and triphosphate. The triphosphate metabolite competes with thymidine for incorporation into viral DNA, thereby causing DNA chain termination and inhibiting the function of HBV DNA polymerase (reverse transcriptase). Clevudine has a long half-life and shows significant reduction of covalently closed circular DNA (cccDNA), therefore the patient is less likely to have a relapse after treatment is discontinued.

      Clevudine Manufacturers

      A Clevudine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Clevudine, including repackagers and relabelers. The FDA regulates Clevudine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Clevudine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

      Clevudine Suppliers

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

      Clevudine KDMF

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

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

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

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

      Clevudine Manufacturers | Traders | Suppliers

      Clevudine Manufacturers, Traders, Suppliers 1
      68

      We have 1 companies offering Clevudine

      Get in contact with the supplier of your choice:

      1. Pharmacostech
      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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