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List of Korea Drug Master Files (KDMF) for Dolutegravir Active Pharmaceutical Ingredient submitted to the Review Authority in Korea and listed on PharmaCompass.com

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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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GlaxoSmithKline Co., Ltd.
2014-08-01
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Shionogi Pharma Co., Ltd....
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  • TABLET;ORAL - EQ 10MG BASE
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  • TABLET;ORAL - EQ 600MG BASE;EQ 50MG BASE;300MG

Looking for 1051375-16-6 / Dolutegravir Sodium API manufacturers, exporters & distributors?

Dolutegravir Sodium manufacturers, exporters & distributors 1

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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 Manufacturers

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

Dolutegravir Suppliers

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

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

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

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

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

Dolutegravir Manufacturers | Traders | Suppliers

Dolutegravir Manufacturers, Traders, Suppliers 1
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We have 2 companies offering Dolutegravir

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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