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01 1Glaxo Wellcome Manufacturing Pte. Ltd@[Micronized Manufacturing Plant]Catalent Micron Technologies Limited

02 1Shionogi Pharma Co., Ltd.@[Some process manufacturers] Fujimoto Chemicals Co., Ltd. Senboku Plant

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PharmaCompass

01

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Dolutegravir sodium

Registrant Name : GlaxoSmithKline Inc.

Registration Date : 2020-08-13

Registration Number : Su231-19-ND

Manufacturer Name : Glaxo Wellcome Manufacturing...

Manufacturer Address : 1 Pioneer Sector 1, Singapore 628413@[Micronising Manufactory]Crossways Boulevard, Cr...

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Dolutegravir sodium (micronized)

Registrant Name : GlaxoSmithKline Inc.

Registration Date : 2014-08-01

Registration Number : Su2480-14-ND

Manufacturer Name : Shionogi Pharma Co., Ltd.@[S...

Manufacturer Address : 224-20, Hiraishiebisuno, Kawauchi-cho, Tokushima, Tokushima 771-0132, Japan@1-24, Rin...

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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.