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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.
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.
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.
A Dolutegravir DMF (Drug Master File) is a document detailing the whole manufacturing process of Dolutegravir active pharmaceutical ingredient (API) in detail. Different forms of Dolutegravir DMFs exist exist since differing nations have different regulations, such as Dolutegravir USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dolutegravir DMF submitted to regulatory agencies in the US is known as a USDMF. Dolutegravir USDMF includes data on Dolutegravir's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dolutegravir USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dolutegravir suppliers with USDMF on PharmaCompass.
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.
A Dolutegravir written confirmation (Dolutegravir WC) is an official document issued by a regulatory agency to a Dolutegravir manufacturer, verifying that the manufacturing facility of a Dolutegravir active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Dolutegravir APIs or Dolutegravir finished pharmaceutical products to another nation, regulatory agencies frequently require a Dolutegravir WC (written confirmation) as part of the regulatory process.
click here to find a list of Dolutegravir suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Dolutegravir as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Dolutegravir API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Dolutegravir as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Dolutegravir and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dolutegravir NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Dolutegravir suppliers with NDC on PharmaCompass.
Dolutegravir Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Dolutegravir GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Dolutegravir GMP manufacturer or Dolutegravir GMP API supplier for your needs.
A Dolutegravir CoA (Certificate of Analysis) is a formal document that attests to Dolutegravir's compliance with Dolutegravir specifications and serves as a tool for batch-level quality control.
Dolutegravir CoA mostly includes findings from lab analyses of a specific batch. For each Dolutegravir CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Dolutegravir may be tested according to a variety of international standards, such as European Pharmacopoeia (Dolutegravir EP), Dolutegravir JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dolutegravir USP).
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