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Also known as: Tenofovir alafenamide fumarate, 1392275-56-7, Gs-7340 hemifumarate, Tenofovir alafenamide hemifumarate, Gs-7340-03, Tenofovir alafenamide fumarate [usan]
Molecular Formula
C46H62N12O14P2
Molecular Weight
1069.0  g/mol
InChI Key
SVUJNSGGPUCLQZ-FQQAACOVSA-N
FDA UNII
FWF6Q91TZO

Tenofovir Alafenamide Fumarate
1 2D Structure

Tenofovir Alafenamide Fumarate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(E)-but-2-enedioic acid;propan-2-yl (2S)-2-[[[(2R)-1-(6-aminopurin-9-yl)propan-2-yl]oxymethyl-phenoxyphosphoryl]amino]propanoate
2.1.2 InChI
InChI=1S/2C21H29N6O5P.C4H4O4/c2*1-14(2)31-21(28)16(4)26-33(29,32-17-8-6-5-7-9-17)13-30-15(3)10-27-12-25-18-19(22)23-11-24-20(18)27;5-3(6)1-2-4(7)8/h2*5-9,11-12,14-16H,10,13H2,1-4H3,(H,26,29)(H2,22,23,24);1-2H,(H,5,6)(H,7,8)/b;;2-1+/t2*15-,16+,33+;/m11./s1
2.1.3 InChI Key
SVUJNSGGPUCLQZ-FQQAACOVSA-N
2.1.4 Canonical SMILES
CC(C)OC(=O)C(C)NP(=O)(COC(C)CN1C=NC2=C(N=CN=C21)N)OC3=CC=CC=C3.CC(C)OC(=O)C(C)NP(=O)(COC(C)CN1C=NC2=C(N=CN=C21)N)OC3=CC=CC=C3.C(=CC(=O)O)C(=O)O
2.1.5 Isomeric SMILES
C[C@H](CN1C=NC2=C(N=CN=C21)N)OC[P@@](=O)(N[C@@H](C)C(=O)OC(C)C)OC3=CC=CC=C3.C[C@H](CN1C=NC2=C(N=CN=C21)N)OC[P@@](=O)(N[C@@H](C)C(=O)OC(C)C)OC3=CC=CC=C3.C(=C/C(=O)O)\C(=O)O
2.2 Other Identifiers
2.2.1 UNII
FWF6Q91TZO
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Gs-7340

2. Gs-734003

3. L-alanine, N-((s)-(((1r)-2-(6-amino-9h-purin-9-yl)-1-methylethoxy)methyl)phenoxyphosphinyl)-, 1-methylethyl Ester

4. Tenofovir Alafenamide

2.3.2 Depositor-Supplied Synonyms

1. Tenofovir Alafenamide Fumarate

2. 1392275-56-7

3. Gs-7340 Hemifumarate

4. Tenofovir Alafenamide Hemifumarate

5. Gs-7340-03

6. Tenofovir Alafenamide Fumarate [usan]

7. Fwf6q91tzo

8. Gs-7340 (hemifumarate)

9. Vemlidy (tn)

10. Taf

11. Chembl2364637

12. Chebi:90923

13. Dtxsid401027740

14. (s)-isopropyl 2-(((s)-((((r)-1-(6-amino-9h-purin-9-yl)propan-2-yl)oxy)methyl)(phenoxy)phosphoryl)amino)propanoate Fumarate(2:1)

15. Ex-a2641

16. Mfcd30534429

17. S4427

18. Ac-30255

19. Tenofovir Alafenamide Fumarate (usan/jan)

20. Tenofovir Alafenamide Fumarate [mi]

21. Tenofovir Alafenamide Fumarate [jan]

22. Tenofovir Alafenamide Fumarate (2:1)

23. D10605

24. Tenofovir Alafenamide Fumarate [who-dd]

25. Tenofovir Alafenamide Fumarate [orange Book]

26. Descovy Component Tenofovir Alafenamide Fumarate

27. Odefsey Component Tenofovir Alafenamide Fumarate

28. Q27162911

29. Symtuza Component Tenofovir Alafenamide Fumarate

30. Biktarvy Component Tenofovir Alafenamide Fumarate

31. Tenofovir Alafenamide Fumarate Component Of Biktarvy

32. Tenofovir Alafenamide Fumarate Component Of Descovy

33. Tenofovir Alafenamide Fumarate Component Of Genvoya

34. Tenofovir Alafenamide Fumarate Component Of Odefsey

35. Tenofovir Alafenamide Fumarate Component Of Symtuza

36. (s)-isopropyl 2-(((s)-((((r)-1-(6-amino-9h-purin-9-yl)propan-2-yl)oxy)methyl)(phenoxy)phosphoryl)amino)propanoate Hemifumarate

37. 1-methylethyl N-((s)-(((1r)-2-(6-amino-9h-purin-9-yl)-1-methylethoxy)methyl(phenoxyphosphinoyl)-l-alaninate, (2e)-2-butenedioate

38. Bis{9-[(2r,5s,7e)-2,7,10-trimethyl-5,8-dioxo-5-phenoxy-3,9-dioxa-6-aza-5lambda5-phosphaundecan-1-yl]-9h-purin-6-aminium} (2e)-but-2-enedioate

39. Bis{propan-2-yl N-[(s)-({[(2r)-1-(6-amino-9h-purin-9-yl)propan-2-yl]oxy}methyl)(phenoxy)phosphoryl]-l-alaninate} (2e)-but-2-enedioate

2.4 Create Date
2013-06-10
3 Chemical and Physical Properties
Molecular Weight 1069.0 g/mol
Molecular Formula C46H62N12O14P2
Hydrogen Bond Donor Count6
Hydrogen Bond Acceptor Count24
Rotatable Bond Count26
Exact Mass1068.39836869 g/mol
Monoisotopic Mass1068.39836869 g/mol
Topological Polar Surface Area362 Ų
Heavy Atom Count74
Formal Charge0
Complexity799
Isotope Atom Count0
Defined Atom Stereocenter Count6
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count1
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count3
4 Drug and Medication Information
4.1 Drug Indication

Vemlidy is indicated for the treatment of chronic hepatitis B in adults and adolescents (aged 12 years and older with body weight at least 35 kg).


5 Pharmacology and Biochemistry
5.1 ATC Code

J05AF


API Reference Price

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HOUSE,H.NO.8-3-166\/7\/1ERRAGADDA, HYDERABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1727375400,"product":"TENOFOVIR ALAFENAMIDE FUMARATE BATCH NO;TAFA24009P1 & TAFA24011P1","address":"N0 116\/117, KIADB INDUSTRIAL AREA,","city":"BANGALORE","supplier":"CDYMAX (INDIA) PHARMA PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"ANKARA","customer":"M\/S.DROGSAN ILACLARI SANAYI VE","customerCountry":"TURKEY","quantity":"17.04","actualQuantity":"17.04","unit":"KGS","unitRateFc":"4500","totalValueFC":"75149.2","currency":"USD","unitRateINR":369577.08978873241,"date":"27-Sep-2024","totalValueINR":"6297593.61","totalValueInUsd":"75149.2","indian_port":"Bangalore Air","hs_no":"29335990","bill_no":"4397887","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"TURKEY","selfForZScoreResived":"Pharma Grade","supplierPort":"Bangalore Air","supplierAddress":"N0 116\/117, KIADB INDUSTRIAL AREA,, 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07-Jan-2021
03-Dec-2024
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DOSAGE - TABLET;ORAL - 150MG;150MG;200MG;EQ 1...DOSAGE - TABLET;ORAL - 150MG;150MG;200MG;EQ 10MG BASE

USFDA APPLICATION NUMBER - 207561

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DOSAGE - TABLET;ORAL - 120MG;EQ 15MG BASE

USFDA APPLICATION NUMBER - 208215

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DOSAGE - TABLET;ORAL - 200MG;EQ 25MG BASE

USFDA APPLICATION NUMBER - 208215

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DOSAGE - TABLET;ORAL - 200MG;EQ 25MG BASE;EQ ...DOSAGE - TABLET;ORAL - 200MG;EQ 25MG BASE;EQ 25MG BASE

USFDA APPLICATION NUMBER - 208351

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DOSAGE - TABLET;ORAL - EQ 30MG BASE;120MG;EQ ...DOSAGE - TABLET;ORAL - EQ 30MG BASE;120MG;EQ 15MG BASE

USFDA APPLICATION NUMBER - 210251

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DOSAGE - TABLET;ORAL - EQ 50MG BASE;200MG;EQ ...DOSAGE - TABLET;ORAL - EQ 50MG BASE;200MG;EQ 25MG BASE

USFDA APPLICATION NUMBER - 210251

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ABOUT THIS PAGE

Tenofovir Alafenamide Fumarate Manufacturers

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

Tenofovir Alafenamide Fumarate Suppliers

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

click here to find a list of Tenofovir Alafenamide Fumarate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Tenofovir Alafenamide Fumarate USDMF

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

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

click here to find a list of Tenofovir Alafenamide Fumarate suppliers with USDMF on PharmaCompass.

Tenofovir Alafenamide Fumarate KDMF

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

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

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

click here to find a list of Tenofovir Alafenamide Fumarate suppliers with KDMF on PharmaCompass.

Tenofovir Alafenamide Fumarate WC

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

click here to find a list of Tenofovir Alafenamide Fumarate suppliers with Written Confirmation (WC) on PharmaCompass.

Tenofovir Alafenamide Fumarate 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 Tenofovir Alafenamide Fumarate as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Tenofovir Alafenamide Fumarate 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 Tenofovir Alafenamide Fumarate 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 Tenofovir Alafenamide Fumarate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tenofovir Alafenamide Fumarate NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Tenofovir Alafenamide Fumarate suppliers with NDC on PharmaCompass.

Tenofovir Alafenamide Fumarate GMP

Tenofovir Alafenamide Fumarate 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 Alafenamide Fumarate 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 Alafenamide Fumarate GMP manufacturer or Tenofovir Alafenamide Fumarate GMP API supplier for your needs.

Tenofovir Alafenamide Fumarate CoA

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

Tenofovir Alafenamide Fumarate CoA mostly includes findings from lab analyses of a specific batch. For each Tenofovir Alafenamide Fumarate 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 Alafenamide Fumarate may be tested according to a variety of international standards, such as European Pharmacopoeia (Tenofovir Alafenamide Fumarate EP), Tenofovir Alafenamide Fumarate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tenofovir Alafenamide Fumarate 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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