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CEP/COS
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JDMF
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VMF
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Australia
DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
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USDMF
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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
About the Company : Gonane Pharma, is a contract pharmaceutical company located in Gujarat, India, specializing in the manufacturing and marketing of Corticosteroids, Hormones, Antivirals, and Oncolog...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
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DOSAGE - TABLET;ORAL - 400MG;300MG;300MG
USFDA APPLICATION NUMBER - 208255
DOSAGE - CAPSULE;ORAL - 100MG **Federal Regis...DOSAGE - CAPSULE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20972
DOSAGE - CAPSULE;ORAL - 200MG **Federal Regis...DOSAGE - CAPSULE;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20972
DOSAGE - CAPSULE;ORAL - 50MG **Federal Regist...DOSAGE - CAPSULE;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20972
DOSAGE - TABLET;ORAL - 300MG **Federal Regist...DOSAGE - TABLET;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21360
DOSAGE - TABLET;ORAL - 600MG
USFDA APPLICATION NUMBER - 21360
DOSAGE - TABLET;ORAL - 600MG;200MG;300MG
USFDA APPLICATION NUMBER - 21937
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REF. STANDARDS & IMPURITIES
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ANALYTICAL
ABOUT THIS PAGE
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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.
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.
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.
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.
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.
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.
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).
The FDA updates the NDC directory daily. The NDC numbers for Efavirenz 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 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.
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 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.
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).
