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

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    Dolutegravir Sodium

    APIs // Active Pharmaceutical Ingredients

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    01 Glaxo Wellcome Manufacturing Pte. Ltd@[Micronization Manufacturer]Catalent Micron Technologies Limited (1)

    02 Shionogi Pharma Co., Ltd.@[Partial process manufacturer] Fujimoto Chemicals Co., Ltd. Senboku Plant (1)

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    01 GlaxoSmithKline Co., Ltd. (2)

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    01 Dolutegravir sodium (1)

    02 Dolutegravir sodium (micronized) (1)

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    01 Japan (1)

    02 United Kingdom (1)

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    GSK

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    Dolutegravir sodium

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    GlaxoSmithKline Co., Ltd.
    2020-08-13
    Wed231-19-ND
    Glaxo Wellcome Manufactur...
    United Kingdom
    1 Pioneer Sector 1, Singa...
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    Shionogi

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      Dolutegravir sodium (micronized)

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      GlaxoSmithKline Co., Ltd.
      2014-08-01
      Wed2480-14-ND
      Shionogi Pharma Co., Ltd....
      Japan
      224-20, Hiraishiebisuno, ...
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      Looking for 1051375-16-6 / Dolutegravir Sodium API manufacturers, exporters & distributors?

      Dolutegravir Sodium manufacturers, exporters & distributors 1

      49

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

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

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

      API | Excipient name

      Dolutegravir Sodium

      Synonyms

      1051375-16-6, Gsk1349572, S/gsk1349572, Tivicay, Gsk-1349572, Gsk 1349572

      Cas Number

      1051375-16-6

      Unique Ingredient Identifier (UNII)

      DKO1W9H7M1

      About Dolutegravir Sodium

      Dolutegravir is an orally bioavailable integrase strand-transfer inhibitor (INSTI), with activity against human immunodeficiency virus type 1 (HIV-1) infection. Upon oral administration, dolutegravir binds to the active site of integrase, an HIV enzyme that catalyzes the transfer of viral genetic material into human chromosomes. This prevents integrase from binding to retroviral deoxyribonucleic acid (DNA), and blocks the strand transfer step, which is essential for the HIV replication cycle. This prevents HIV-1 replication.

      Dolutegravir Sodium Manufacturers

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

      Dolutegravir Sodium Suppliers

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

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

      Dolutegravir Sodium KDMF

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

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

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

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

      Dolutegravir Sodium Manufacturers | Traders | Suppliers

      Dolutegravir Sodium Manufacturers, Traders, Suppliers 1
      33

      We have 2 companies offering Dolutegravir Sodium

      Get in contact with the supplier of your choice:

      1. GSK
      2. Shionogi
      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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