Synopsis
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CEP/COS
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FDA Orange Book
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1. 94882wb39e
2. 1637632-97-3
3. 2,4,6,8-tetraoxa-5-phosphanonanedioic Acid, 5-(((1r)-2-(6-amino-9h-purin-9-yl)-1-methylethoxy)methyl)-, 1,9-bis(1-methylethyl) Ester, 5-oxide, Butanedioate (1:1)
4. Unii-94882wb39e
5. Schembl984685
6. Tenofovir Disoproxil Succinate [who-dd]
7. Q27271655
Molecular Weight | 637.5 g/mol |
---|---|
Molecular Formula | C23H36N5O14P |
Hydrogen Bond Donor Count | 3 |
Hydrogen Bond Acceptor Count | 18 |
Rotatable Bond Count | 20 |
Exact Mass | 637.19963784 g/mol |
Monoisotopic Mass | 637.19963784 g/mol |
Topological Polar Surface Area | 260 Ų |
Heavy Atom Count | 43 |
Formal Charge | 0 |
Complexity | 791 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 1 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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Market Place
ANALYTICAL
ABOUT THIS PAGE
A Tenofovir Disoproxil Succinate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tenofovir Disoproxil Succinate, including repackagers and relabelers. The FDA regulates Tenofovir Disoproxil Succinate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tenofovir Disoproxil Succinate 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 Tenofovir Disoproxil Succinate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tenofovir Disoproxil Succinate supplier is an individual or a company that provides Tenofovir Disoproxil Succinate active pharmaceutical ingredient (API) or Tenofovir Disoproxil Succinate finished formulations upon request. The Tenofovir Disoproxil Succinate suppliers may include Tenofovir Disoproxil Succinate API manufacturers, exporters, distributors and traders.
click here to find a list of Tenofovir Disoproxil Succinate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 Tenofovir Disoproxil Succinate Drug Master File in Korea (Tenofovir Disoproxil Succinate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Tenofovir Disoproxil Succinate. The MFDS reviews the Tenofovir Disoproxil Succinate KDMF as part of the drug registration process and uses the information provided in the Tenofovir Disoproxil Succinate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Tenofovir Disoproxil Succinate 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 Tenofovir Disoproxil Succinate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Tenofovir Disoproxil Succinate suppliers with KDMF on PharmaCompass.
A Tenofovir Disoproxil Succinate written confirmation (Tenofovir Disoproxil Succinate WC) is an official document issued by a regulatory agency to a Tenofovir Disoproxil Succinate manufacturer, verifying that the manufacturing facility of a Tenofovir Disoproxil Succinate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Tenofovir Disoproxil Succinate APIs or Tenofovir Disoproxil Succinate finished pharmaceutical products to another nation, regulatory agencies frequently require a Tenofovir Disoproxil Succinate WC (written confirmation) as part of the regulatory process.
click here to find a list of Tenofovir Disoproxil Succinate 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 Tenofovir Disoproxil Succinate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Tenofovir Disoproxil Succinate 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 Tenofovir Disoproxil Succinate 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 Tenofovir Disoproxil Succinate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tenofovir Disoproxil Succinate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Tenofovir Disoproxil Succinate suppliers with NDC on PharmaCompass.
Tenofovir Disoproxil Succinate 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 Tenofovir Disoproxil Succinate 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 Tenofovir Disoproxil Succinate GMP manufacturer or Tenofovir Disoproxil Succinate GMP API supplier for your needs.
A Tenofovir Disoproxil Succinate CoA (Certificate of Analysis) is a formal document that attests to Tenofovir Disoproxil Succinate's compliance with Tenofovir Disoproxil Succinate specifications and serves as a tool for batch-level quality control.
Tenofovir Disoproxil Succinate CoA mostly includes findings from lab analyses of a specific batch. For each Tenofovir Disoproxil Succinate 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.
Tenofovir Disoproxil Succinate may be tested according to a variety of international standards, such as European Pharmacopoeia (Tenofovir Disoproxil Succinate EP), Tenofovir Disoproxil Succinate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tenofovir Disoproxil Succinate USP).
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