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PharmaCompass offers a list of Etravirine 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 Etravirine manufacturer or Etravirine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Etravirine manufacturer or Etravirine supplier.
PharmaCompass also assists you with knowing the Etravirine API Price utilized in the formulation of products. Etravirine API Price is not always fixed or binding as the Etravirine Price is obtained through a variety of data sources. The Etravirine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Etravirine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Etravirine, including repackagers and relabelers. The FDA regulates Etravirine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Etravirine 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 Etravirine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Etravirine supplier is an individual or a company that provides Etravirine active pharmaceutical ingredient (API) or Etravirine finished formulations upon request. The Etravirine suppliers may include Etravirine API manufacturers, exporters, distributors and traders.
click here to find a list of Etravirine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Etravirine DMF (Drug Master File) is a document detailing the whole manufacturing process of Etravirine active pharmaceutical ingredient (API) in detail. Different forms of Etravirine DMFs exist exist since differing nations have different regulations, such as Etravirine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Etravirine DMF submitted to regulatory agencies in the US is known as a USDMF. Etravirine USDMF includes data on Etravirine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Etravirine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Etravirine 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 Etravirine Drug Master File in Korea (Etravirine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Etravirine. The MFDS reviews the Etravirine KDMF as part of the drug registration process and uses the information provided in the Etravirine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Etravirine 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 Etravirine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Etravirine suppliers with KDMF on PharmaCompass.
A Etravirine written confirmation (Etravirine WC) is an official document issued by a regulatory agency to a Etravirine manufacturer, verifying that the manufacturing facility of a Etravirine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Etravirine APIs or Etravirine finished pharmaceutical products to another nation, regulatory agencies frequently require a Etravirine WC (written confirmation) as part of the regulatory process.
click here to find a list of Etravirine 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 Etravirine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Etravirine 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 Etravirine 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 Etravirine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Etravirine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Etravirine suppliers with NDC on PharmaCompass.
Etravirine 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 Etravirine 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 Etravirine GMP manufacturer or Etravirine GMP API supplier for your needs.
A Etravirine CoA (Certificate of Analysis) is a formal document that attests to Etravirine's compliance with Etravirine specifications and serves as a tool for batch-level quality control.
Etravirine CoA mostly includes findings from lab analyses of a specific batch. For each Etravirine 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.
Etravirine may be tested according to a variety of international standards, such as European Pharmacopoeia (Etravirine EP), Etravirine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Etravirine USP).
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