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| Molecular Weight | 277.28 g/mol |
|---|---|
| Molecular Formula | C12H15N5O3 |
| XLogP3 | -0.8 |
| Hydrogen Bond Donor Count | 4 |
| Hydrogen Bond Acceptor Count | 4 |
| Rotatable Bond Count | 2 |
| Exact Mass | 277.11748936 g/mol |
| Monoisotopic Mass | 277.11748936 g/mol |
| Topological Polar Surface Area | 126 A^2 |
| Heavy Atom Count | 20 |
| Formal Charge | 0 |
| Complexity | 480 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 3 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
| 1 of 4 | |
|---|---|
| Drug Name | Baraclude |
| PubMed Health | Entecavir (By mouth) |
| Drug Classes | Antiviral |
| Drug Label | BARACLUDE is the tradename for entecavir, a guanosine nucleoside analogue with selective activity against HBV. The chemical name for entecavir is 2-amino-1,9-dihydro-9-[(1S,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]-6H-purin-6-one,... |
| Active Ingredient | Entecavir |
| Dosage Form | Tablet; Solution |
| Route | Oral |
| Strength | 0.5mg; 0.05mg/ml; 1mg |
| Market Status | Prescription |
| Company | Bristol Myers Squibb |
| 2 of 4 | |
|---|---|
| Drug Name | Entecavir |
| PubMed Health | Entecavir (By mouth) |
| Drug Classes | Antiviral |
| Drug Label | BARACLUDE is the tradename for entecavir, a guanosine nucleoside analogue with selective activity against HBV. The chemical name for entecavir is 2-amino-1,9-dihydro-9-[(1S,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]-6H-purin-6-one,... |
| Active Ingredient | Entecavir |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | 0.5mg; 1mg |
| Market Status | Prescription |
| Company | Teva Pharms Usa |
| 3 of 4 | |
|---|---|
| Drug Name | Baraclude |
| PubMed Health | Entecavir (By mouth) |
| Drug Classes | Antiviral |
| Drug Label | BARACLUDE is the tradename for entecavir, a guanosine nucleoside analogue with selective activity against HBV. The chemical name for entecavir is 2-amino-1,9-dihydro-9-[(1S,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]-6H-purin-6-one,... |
| Active Ingredient | Entecavir |
| Dosage Form | Tablet; Solution |
| Route | Oral |
| Strength | 0.5mg; 0.05mg/ml; 1mg |
| Market Status | Prescription |
| Company | Bristol Myers Squibb |
| 4 of 4 | |
|---|---|
| Drug Name | Entecavir |
| PubMed Health | Entecavir (By mouth) |
| Drug Classes | Antiviral |
| Drug Label | BARACLUDE is the tradename for entecavir, a guanosine nucleoside analogue with selective activity against HBV. The chemical name for entecavir is 2-amino-1,9-dihydro-9-[(1S,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]-6H-purin-6-one,... |
| Active Ingredient | Entecavir |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | 0.5mg; 1mg |
| Market Status | Prescription |
| Company | Teva Pharms Usa |

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PharmaCompass offers a list of Entecavir 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 Entecavir manufacturer or Entecavir supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Entecavir manufacturer or Entecavir supplier.
PharmaCompass also assists you with knowing the Entecavir API Price utilized in the formulation of products. Entecavir API Price is not always fixed or binding as the Entecavir Price is obtained through a variety of data sources. The Entecavir Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A ETV manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ETV, including repackagers and relabelers. The FDA regulates ETV manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ETV 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 ETV manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A ETV supplier is an individual or a company that provides ETV active pharmaceutical ingredient (API) or ETV finished formulations upon request. The ETV suppliers may include ETV API manufacturers, exporters, distributors and traders.
click here to find a list of ETV suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A ETV DMF (Drug Master File) is a document detailing the whole manufacturing process of ETV active pharmaceutical ingredient (API) in detail. Different forms of ETV DMFs exist exist since differing nations have different regulations, such as ETV USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A ETV DMF submitted to regulatory agencies in the US is known as a USDMF. ETV USDMF includes data on ETV's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The ETV USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of ETV suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The ETV Drug Master File in Japan (ETV JDMF) empowers ETV API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the ETV JDMF during the approval evaluation for pharmaceutical products. At the time of ETV JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of ETV suppliers with JDMF 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 ETV Drug Master File in Korea (ETV KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of ETV. The MFDS reviews the ETV KDMF as part of the drug registration process and uses the information provided in the ETV KDMF to evaluate the safety and efficacy of the drug.
After submitting a ETV 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 ETV API can apply through the Korea Drug Master File (KDMF).
click here to find a list of ETV suppliers with KDMF on PharmaCompass.
A ETV CEP of the European Pharmacopoeia monograph is often referred to as a ETV Certificate of Suitability (COS). The purpose of a ETV CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of ETV EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of ETV to their clients by showing that a ETV CEP has been issued for it. The manufacturer submits a ETV CEP (COS) as part of the market authorization procedure, and it takes on the role of a ETV CEP holder for the record. Additionally, the data presented in the ETV CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the ETV DMF.
A ETV CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. ETV CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of ETV suppliers with CEP (COS) on PharmaCompass.
A ETV written confirmation (ETV WC) is an official document issued by a regulatory agency to a ETV manufacturer, verifying that the manufacturing facility of a ETV active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting ETV APIs or ETV finished pharmaceutical products to another nation, regulatory agencies frequently require a ETV WC (written confirmation) as part of the regulatory process.
click here to find a list of ETV 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 ETV as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for ETV 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 ETV 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 ETV and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a ETV NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of ETV suppliers with NDC on PharmaCompass.
ETV 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 ETV 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 ETV GMP manufacturer or ETV GMP API supplier for your needs.
A ETV CoA (Certificate of Analysis) is a formal document that attests to ETV's compliance with ETV specifications and serves as a tool for batch-level quality control.
ETV CoA mostly includes findings from lab analyses of a specific batch. For each ETV 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.
ETV may be tested according to a variety of international standards, such as European Pharmacopoeia (ETV EP), ETV JP (Japanese Pharmacopeia) and the US Pharmacopoeia (ETV USP).