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Overview of Efavirenz

API Suppliers

API Suppliers

US DMFs Filed

US DMFs Filed

CEP/COS Certifications

CEP/COS Certifications


JDMFs Filed

JDMFs Filed


Other Certificates

Other Certificates

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Other Suppliers

USA (Orange Book)

USA (Orange Book)







South Africa

South Africa

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Uploaded Dossiers


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  • TABLET;ORAL - 400MG;300MG;300MG
  • CAPSULE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - 600MG;200MG;300MG
  • TABLET;ORAL - 600MG;300MG;300MG

Looking for 154598-52-4 / Efavirenz API manufacturers, exporters & distributors?


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

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

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

API | Excipient name



154598-52-4, Sustiva, Stocrin, Dmp-266, Dmp 266, Efv

Cas Number


Unique Ingredient Identifier (UNII)


About Efavirenz

Efavirenz is a synthetic non-nucleoside reverse transcriptase (RT) inhibitor with antiviral activity. Efavirenz binds directly to the human immunodeficiency virus type 1 (HIV-1) RT, an RNA-dependent DNA polymerase, blocking its function in viral DNA replication. In combination with other antiretroviral drugs, this agent has been shown to significantly reduce HIV viral load, retarding or preventing damage to the immune system and reducing the risk of developing AIDS. Efavirenz induces activity of the cytochrome P450 system, accelerating its own metabolism.

Efavirenz Manufacturers

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

Efavirenz Suppliers

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

CLICK HERE to find a list of Efavirenz suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Efavirenz USDMF

A Efavirenz DMF (Drug Master File) is a document detailing the whole manufacturing process of Efavirenz active pharmaceutical ingredient (API) in detail. Different forms of Efavirenz DMFs exist exist since differing nations have different regulations, such as Efavirenz USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Efavirenz DMF submitted to regulatory agencies in the US is known as a USDMF. Efavirenz USDMF includes data on Efavirenz's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Efavirenz USDMF is kept confidential to protect the manufacturer’s intellectual property.

CLICK HERE to find a list of Efavirenz suppliers with USDMF on PharmaCompass.

Efavirenz KDMF

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

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

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

CLICK HERE to find a list of Efavirenz suppliers with KDMF on PharmaCompass.

Efavirenz WC

A Efavirenz written confirmation (Efavirenz WC) is an official document issued by a regulatory agency to a Efavirenz manufacturer, verifying that the manufacturing facility of a Efavirenz active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Efavirenz APIs or Efavirenz finished pharmaceutical products to another nation, regulatory agencies frequently require a Efavirenz WC (written confirmation) as part of the regulatory process.

CLICK HERE to find a list of Efavirenz suppliers with Written Confirmation (WC) on PharmaCompass.

Efavirenz NDC

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 Efavirenz as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Efavirenz API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 Efavirenz 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Efavirenz and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Efavirenz NDC to their finished compounded human drug products, they may choose to do so.

CLICK HERE to find a list of Efavirenz suppliers with NDC on PharmaCompass.

Efavirenz GMP

Efavirenz 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 Efavirenz 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 Efavirenz GMP manufacturer or Efavirenz GMP API supplier for your needs.

Efavirenz CoA

A Efavirenz CoA (Certificate of Analysis) is a formal document that attests to Efavirenz's compliance with Efavirenz specifications and serves as a tool for batch-level quality control.

Efavirenz CoA mostly includes findings from lab analyses of a specific batch. For each Efavirenz 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.

Efavirenz may be tested according to a variety of international standards, such as European Pharmacopoeia (Efavirenz EP), Efavirenz JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Efavirenz USP).

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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