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Chemistry

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Also known as: 1377049-84-7, Gs-5816, Gs5816, Kcu0c7rs7z, Gs 5816, Methyl ((r)-2-((2s,4s)-2-(5-(2-((2s,5s)-1-((methoxycarbonyl)-l-valyl)-5-methylpyrrolidin-2-yl)-1,11-dihydroisochromeno[4',3':6,7]naphtho[1,2-d]imidazol-9-yl)-1h-imidazol-2-yl)-4-(methoxymethyl)pyrrolidin-1-yl)-2-oxo-1-phenylethyl)carbamate
Molecular Formula
C49H54N8O8
Molecular Weight
883.0  g/mol
InChI Key
FHCUMDQMBHQXKK-CDIODLITSA-N
FDA UNII
KCU0C7RS7Z

Velpatasvir
Velpatasvir is an orally available inhibitor of the hepatitis C virus (HCV) non-structural protein 5A (NS5A) replication complex, with potential activity against HCV genotypes 1-6. Although the exact mechanism of action of velpatasvir has not yet been completely determined, upon oral administration and intracellular uptake, it appears to bind to domain I of the NS5A protein. This inhibits the activity of the NS5A protein and results in the disruption of the viral RNA replication complex, blockage of viral HCV RNA production, and inhibition of viral replication. NS5A, a zinc-binding and proline-rich hydrophilic phosphoprotein, plays a crucial role in HCV RNA replication. HCV is a small, enveloped, single-stranded RNA virus belonging to the Flaviviridae family.
Velpatasvir is a Hepatitis C Virus NS5A Inhibitor. The mechanism of action of velpatasvir is as a Breast Cancer Resistance Protein Inhibitor, and P-Glycoprotein Inhibitor, and Organic Anion Transporting Polypeptide 1B1 Inhibitor, and Organic Anion Transporting Polypeptide 1B3 Inhibitor, and Organic Anion Transporting Polypeptide 2B1 Inhibitor.
1 2D Structure

Velpatasvir

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
methyl N-[(1R)-2-[(2S,4S)-2-[5-[6-[(2S,5S)-1-[(2S)-2-(methoxycarbonylamino)-3-methylbutanoyl]-5-methylpyrrolidin-2-yl]-21-oxa-5,7-diazapentacyclo[11.8.0.03,11.04,8.014,19]henicosa-1(13),2,4(8),5,9,11,14(19),15,17-nonaen-17-yl]-1H-imidazol-2-yl]-4-(methoxymethyl)pyrrolidin-1-yl]-2-oxo-1-phenylethyl]carbamate
2.1.2 InChI
InChI=1S/C49H54N8O8/c1-26(2)41(54-48(60)63-5)47(59)57-27(3)12-17-38(57)45-51-36-16-14-30-20-35-33-15-13-31(19-32(33)25-65-40(35)21-34(30)43(36)53-45)37-22-50-44(52-37)39-18-28(24-62-4)23-56(39)46(58)42(55-49(61)64-6)29-10-8-7-9-11-29/h7-11,13-16,19-22,26-28,38-39,41-42H,12,17-18,23-25H2,1-6H3,(H,50,52)(H,51,53)(H,54,60)(H,55,61)/t27-,28-,38-,39-,41-,42+/m0/s1
2.1.3 InChI Key
FHCUMDQMBHQXKK-CDIODLITSA-N
2.1.4 Canonical SMILES
CC1CCC(N1C(=O)C(C(C)C)NC(=O)OC)C2=NC3=C(N2)C=CC4=CC5=C(C=C43)OCC6=C5C=CC(=C6)C7=CN=C(N7)C8CC(CN8C(=O)C(C9=CC=CC=C9)NC(=O)OC)COC
2.1.5 Isomeric SMILES
C[C@H]1CC[C@H](N1C(=O)[C@H](C(C)C)NC(=O)OC)C2=NC3=C(N2)C=CC4=CC5=C(C=C43)OCC6=C5C=CC(=C6)C7=CN=C(N7)[C@@H]8C[C@@H](CN8C(=O)[C@@H](C9=CC=CC=C9)NC(=O)OC)COC
2.2 Other Identifiers
2.2.1 UNII
KCU0C7RS7Z
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Gs-5816

2.3.2 Depositor-Supplied Synonyms

1. 1377049-84-7

2. Gs-5816

3. Gs5816

4. Kcu0c7rs7z

5. Gs 5816

6. Methyl ((r)-2-((2s,4s)-2-(5-(2-((2s,5s)-1-((methoxycarbonyl)-l-valyl)-5-methylpyrrolidin-2-yl)-1,11-dihydroisochromeno[4',3':6,7]naphtho[1,2-d]imidazol-9-yl)-1h-imidazol-2-yl)-4-(methoxymethyl)pyrrolidin-1-yl)-2-oxo-1-phenylethyl)carbamate

7. Methyl [(2s)-1-[(2s,5s)-2-[9-[2-[(2s,4s)-1-[(2r)-2-[(methoxycarbonyl)amino]-2-phenylacetyl]-4-(methoxymethyl)pyrrolidin-2-yl]-1h-imidazol-5-yl]-1,11-dihydroisochromeno[4',3':6,7]naphtho[1,2-d]imidazol-2-yl]-5-methylpyrrolidin-1-yl]-3-methyl-1-oxobutan-2-yl]carbamate

8. Methyl N-[(1r)-2-[(2s,4s)-2-[5-[6-[(2s,5s)-1-[(2s)-2-(methoxycarbonylamino)-3-methylbutanoyl]-5-methylpyrrolidin-2-yl]-21-oxa-5,7-diazapentacyclo[11.8.0.03,11.04,8.014,19]henicosa-1(13),2,4(8),5,9,11,14(19),15,17-nonaen-17-yl]-1h-imidazol-2-yl]-4-(methoxymethyl)pyrrolidin-1-yl]-2-oxo-1-phenylethyl]carbamate

9. Unii-kcu0c7rs7z

10. Velpatasvir [usan:inn]

11. Verpatasvir

12. Methyl ((2s)-1-((2s,5s)-2-(9-(2-((2s,4s)-1-((2r)-2-((methoxycarbonyl)amino)-2-phenylacetyl)-4-(methoxymethyl)pyrrolidin-2-yl)-1h-imidazol-5-yl)-1,11-dihydroisochromeno[4',3':6,7]naphtho[1,2-d]imidazol-2-yl)-5-methylpyrrolidin-1-yl)-3-methyl-1-oxobutan-2-yl)carbamate

13. Methyl {(2s)-1-[(2s,5s)-2-(9-{2-[(2s,4s)-1-{(2r)-2-[(methoxycarbonyl)amino]-2-phenylacetyl}-4-(methoxymethyl)pyrrolidin-2-yl]-1h-imidazol-5-yl}-1,11-dihydroisochromeno[4',3':6,7]naphtho[1,2-d]imidazol-2-yl)-5-methylpyrrolidin-1-yl]-3-methyl-1-oxobutan-2-yl}carbamate

14. Velpatasvir [inn]

15. Velpatasvir(gs5816)

16. Velpatasvir [mi]

17. Velpatasvir [jan]

18. Velpatasvir; Gs-5816

19. Velpatasvir [usan]

20. Velpatasvir [who-dd]

21. Velpatasvir (jan/usan/inn)

22. Schembl8756902

23. Chembl3545062

24. Schembl19236068

25. Gtpl11269

26. Amy4211

27. Dtxsid70722565

28. Velpatasvir [orange Book]

29. Chebi:133009

30. Epclusa (sofosbuvir + Velpatasvir)

31. Vosevi Component Velpatasvir

32. Bcp13813

33. Epclusa Component Velpatasvir

34. Ex-a2320

35. Bdbm50521720

36. Mfcd28411371

37. S3724

38. Velpatasvir Component Of Vosevi

39. Zinc203686879

40. Ccg-270553

41. Cs-5977

42. Db11613

43. Velpatasvir Component Of Epclusa

44. Ncgc00522503-01

45. Ncgc00522503-02

46. Ac-28744

47. As-35237

48. Hy-12530

49. Ft-0700879

50. J3.631.686a

51. D10806

52. Gs-5816;gs5816;gs 5816

53. Vosevi (sofosbuvir + Velpatasvir + Voxilaprevi)

54. A886410

55. Q25018296

56. Carbamic Acid, N-[(1r)-2-[(2s,4s)-2-[5-[1,11-dihydro-2-[(2s,5s)-1-[(2s)-2-[(methoxycarbonyl)amino]-3-methyl-1-oxobutyl]-5-methyl-2-pyrrolidinyl][2]benzopyrano[4,3:6,7]naphth[1,2-d]imidazol-9-yl]-1h-imidazol-2-yl]-4-(methoxymethyl)-1-pyrrolidinyl]-2-oxo-1-phenylethyl]-, Methyl Ester

57. Methyl {(2s)-1-[(2s,5s)-2-(9-{2-[(2s,4s)-1-{(2r)-2-[(methoxycarbonyl)amino]-2-phenylacetyl}-4-(methoxymethyl)pyrrolidin-2-yl]-1h-imidazol-4-yl}-1,11-dihydro[2]benzopyrano[4',3':6,7]naphtho[1,2-d]imidazol-2-yl)-5-methylpyrrolidin-1-yl]-3-methyl-1-oxobutan-2-yl}carbamate

58. Methyl N-[(1r)-2-[(2s,4s)-2-(5-{6-[(2s,5s)-1-[(2s)-2-[(methoxycarbonyl)amino]-3-methylbutanoyl]-5-methylpyrrolidin-2-yl]-21-oxa-5,7-diazapentacyclo[11.8.0.0?,??.0?,?.0??,??]henicosa-1,3,6,8,10,12,14,16,18-nonaen-17-yl}-1h-imidazol-2-yl)-4-(methoxymethyl)pyrrolidin-1-yl]-2-oxo-1-phenylethyl]carbamate

59. Methyl N-[(1r)-2-[(2s,4s)-2-(5-{6-[(2s,5s)-1-[(2s)-2-[(methoxycarbonyl)amino]-3-methylbutanoyl]-5-methylpyrrolidin-2-yl]-21-oxa-5,7-diazapentacyclo[11.8.0.03,11.0?,?.01?,1?]henicosa-1,3,6,8,10,12,14,16,18-nonaen-17-yl}-1h-imidazol-2-yl)-4-(methoxymethyl)pyrrolidin-1-yl]-2-oxo-1-phenylethyl]carbamate

60. Methyl{(2s)-1-[(2s,5s)-2-(9-{2-[(2s,4s)-1-{(2r)-2-[(methoxycarbonyl)amino]-2-phenylacetyl}-4-(methoxymethyl)pyrrolidin-2-yl]-1h-imidazol-5-yl}-1,11-dihydroisochromeno[4',3':6,7]naphtho[1,2-d]imidazol-2-yl)-5-methylpyrrolidin-1-yl]-3-methyl-1-oxobutan-2-yl}carbamate

2.4 Create Date
2012-11-30
3 Chemical and Physical Properties
Molecular Weight 883.0 g/mol
Molecular Formula C49H54N8O8
XLogP36.2
Hydrogen Bond Donor Count4
Hydrogen Bond Acceptor Count10
Rotatable Bond Count13
Exact Mass882.40646071 g/mol
Monoisotopic Mass882.40646071 g/mol
Topological Polar Surface Area193 Ų
Heavy Atom Count65
Formal Charge0
Complexity1690
Isotope Atom Count0
Defined Atom Stereocenter Count6
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameEPCLUSA
Active IngredientSOFOSBUVIR; VELPATASVIR
CompanyGILEAD SCIENCES INC (Application Number: N208341. Patents: 7964580, 8334270, 8575135, 8580765, 8618076, 8633309, 8735372, 8889159, 8921341, 8940718, 9085573, 9284342, 9757406)

2 of 2  
Drug NameVOSEVI
Active IngredientSOFOSBUVIR; VELPATASVIR; VOXILAPREVIR
CompanyGILEAD SCIENCES INC (Application Number: N209195. Patents: 7964580, 8334270, 8575135, 8580765, 8618076, 8633309, 8735372, 8889159, 8921341, 8940718, 9085573, 9284342, 9296782, 9585906)

4.2 Drug Indication

Velpatasvir is used in combination therapy with other antiviral medications to treat chronic hepatitis C virus (HCV) infected patients with HCV genoptypes 1-6, and to treat HCV and HIV co-infected patients. Depending on the level of cirrhosis or decompensation, combination therapy can also include therapy with [DB00811]. When used in combination with [DB08934] as the combination product Epclusa, Velpatasvir is indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis, or in combination with [DB00811] if associated with decompensated cirrhosis.


FDA Label


5 Pharmacology and Biochemistry
5.1 Pharmacology

Velpatasvir is a small molecule direct-acting antiviral used in the treatment of hepatitis C in combination with sofosbuvir. Velpatasvir prevents viral replication by inhibiting non-structural protein 5A (NS5A). At a dose 5 times the recommended dose, velpatasvir does not prolong QTc interval to any clinically relevant extent.


5.2 MeSH Pharmacological Classification

Antiviral Agents

Agents used in the prophylaxis or therapy of VIRUS DISEASES. Some of the ways they may act include preventing viral replication by inhibiting viral DNA polymerase; binding to specific cell-surface receptors and inhibiting viral penetration or uncoating; inhibiting viral protein synthesis; or blocking late stages of virus assembly. (See all compounds classified as Antiviral Agents.)


5.3 FDA Pharmacological Classification
5.3.1 Active Moiety
VELPATASVIR
5.3.2 FDA UNII
KCU0C7RS7Z
5.3.3 Pharmacological Classes
Mechanisms of Action [MoA] - Organic Anion Transporting Polypeptide 2B1 Inhibitors
5.4 Absorption, Distribution and Excretion

Absorption

Oral bioavailability of 25-30%.


Route of Elimination

94% excreted in feces with 77% as parent compound. 0.4% excreted in urine.


Volume of Distribution

1.4-1.6 L/kg.


Clearance

Estimated 0.12 L/h/kg [A19175.


5.5 Metabolism/Metabolites

Some metabolism by CYP2B6, CYP2C8, and CYP3A4.


5.6 Biological Half-Life

15h.


5.7 Mechanism of Action

Velpatasvir's mechanism of action is likely similar to other selective NS5A inhibitors which bind domain I of NS5A consisting of amino acids 33-202. NS5A inhibitors compete with RNA for binding at this site. It is also thought that NS5A inhibitors bind the target during its action in replication when the binding site is exposed. Inhibition of NS5A is also known to produce redistribution of the protein to lipid droplets. The exact role of NS5A in RNA replication is not yet understood although it is known to be an important component.


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Century Pharmaceuticals

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Hetero Drugs

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Velpatasvir IH

Date of Issue : 2025-09-03

Valid Till : 2028-08-08

Written Confirmation Number : WC-0041

Address of the Firm : Unit-I, Sy. No. 10, I.D.A, Gaddapotharam (V), Jinnaram (M), Sangareddy District,...

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Viatris

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Velpatasvir IH

Date of Issue : 2023-05-10

Valid Till : 2026-05-10

Written Confirmation Number : WC-0015

Address of the Firm : Unit-8, G.Chodavaram village, Pusapatirega Mandal, Vizianagaram District-535204,...

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Yuhan Corporation

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Velpatasvir

Registrant Name : Gilead Sciences Korea Ltd.

Registration Date : 2022-02-17

Registration Number : Su205-22-ND

Manufacturer Name : Yuhan Chemical Co., Ltd.

Manufacturer Address : 162 Cheongwon Industrial Complex 8-gil, Mado-myeon, Hwaseong-si, Gyeonggi-do

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Velpatasvir

Registrant Name : Gilead Sciences Korea Ltd.

Registration Date : 2022-02-17

Registration Number : Su205-23-ND

Manufacturer Name : Yuhan Chemical Co., Ltd.

Manufacturer Address : 402, 5-ba, Sihwa Industrial Complex, 45 Jiwon-ro, Danwon-gu, Ansan-si, Gyeonggi-do (S...

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VELPATASVIR

NDC Package Code : 48087-0123

Start Marketing Date : 2015-12-30

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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VELPATASVIR

NDC Package Code : 48087-0124

Start Marketing Date : 2016-11-23

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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Yuhan Chemical Inc

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VELPATASVIR

NDC Package Code : 66721-800

Start Marketing Date : 2016-10-28

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (10kg/10kg)

Marketing Category : BULK INGREDIENT

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Virtual BoothCentury has been an API manufacturer for over 40 years & is the partner of choice for multipurpose custom manufacturing projects.

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Velpatasvir

About the Company : Century Pharmaceuticals, established in 1982, has 40 years of experience in manufacturing APIs. It has been supplying APIs produced in-house to several major pharma companies in In...

Century Pharmaceuticals, established in 1982, has 40 years of experience in manufacturing APIs. It has been supplying APIs produced in-house to several major pharma companies in India and abroad. Its APIs are manufactured in accordance with cGMP, 21CFR part 10 and ICH guidelines. It also produces intermediates and develops new APIs as per the needs of its clients. Century conducts biotechnological research that focuses on human therapeutic proteins. Currently, research is underway to find treatments for asthma, mastocytosis and basophilic leukemia. Century supplies research-grade biotech products and a wide range of animal health products.
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Velpatasvir

About the Company : Aspire group was established in the year 2000 with a motto of quality drug for better health of all. In its journey till date, aspire has developed enormous reputation, consistent ...

Aspire group was established in the year 2000 with a motto of quality drug for better health of all. In its journey till date, aspire has developed enormous reputation, consistent growth, unique technologies and world class quality healthcare products. Aspire is pioneer in manufacturing and sourcing unique healthcare products. True to the statement, “Where the future started yesterday” with a foresight on the current trends in the healthcare market, Aspire has grown from strength combining its research strength, Human resources and well established quality systems. Aspire has crossed numerous milestones in a comparatively short period since its inception.
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Velpatasvir

About the Company : Bulat Pharmaceutical is a fast growing pharmaceutical company, founded in the year 2017, Bulat Pharmaceutical is engaged in the manufacturing and sales of high quality APIs and Int...

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Velpatasvir

About the Company : Changzhou Pharmaceutical Factory (CPF) is a subsidiary company of Shanghai Pharma Holdings Co., Ltd., It is headquartered in Changzhou, Jiangsu Province, China. The company was fou...

Changzhou Pharmaceutical Factory (CPF) is a subsidiary company of Shanghai Pharma Holdings Co., Ltd., It is headquartered in Changzhou, Jiangsu Province, China. The company was founded in 1949 by (Tan Ruiting) with a registered capital of 108 million yuan and the company was restructured as a Changzhou pharmaceutical Factory under the aegis of the Shanghai Pharma Group. The company mainly involves leading pharmaceutical manufacturers a wide range of key Intermediates, Active pharmaceutical ingredients, and Finished Formulations that meet with global standards.
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05

Aus. Peptide Conference
Not Confirmed
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Aus. Peptide Conference
Not Confirmed

Velpatasvir

About the Company : Globe Quimica S.A. is a major Brazilian API producer, GMP certificated by ANVISA, manufactures more than 20 different API's such as Antiretrovirals, Anxiolytic, Antidepressant, Ant...

Globe Quimica S.A. is a major Brazilian API producer, GMP certificated by ANVISA, manufactures more than 20 different API's such as Antiretrovirals, Anxiolytic, Antidepressant, Antithrombotic, Analgesic. In 2012 Globe Quimica has started-up its new API plant for Active Ingredients for Oncologic Drugs.
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06

Aus. Peptide Conference
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Aus. Peptide Conference
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Velpatasvir

About the Company : Mangalam Drugs & Organics Limited started manufacturing APIs and intermediates in 1977 in Gujarat, India. It has a multi-product manufacturing facility and an in-house R&D lab reco...

Mangalam Drugs & Organics Limited started manufacturing APIs and intermediates in 1977 in Gujarat, India. It has a multi-product manufacturing facility and an in-house R&D lab recognized by the Department of Scientific and Industrial Research, India. Mangalam has established a reputation as a one-stop shop for anti-malaria API and its API manufacturing plant is approved by WHO-GENEVA GMP and EDQM. Mangalam has an agreement with the Clinton Health Access Initiative for the supply of anti-malaria APIs worldwide. It has a wide range of products and is the largest manufacturer of some products in the world. It is among the top companies in Asia.
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07

Viatris

U.S.A
Aus. Peptide Conference
Not Confirmed
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Viatris

U.S.A
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Aus. Peptide Conference
Not Confirmed

Velpatasvir

About the Company : In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (N...

In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) is a global healthcare company empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable operations, develop innovative solutions and leverage our collective expertise to connect more people to more products and services through our one-of-a-kind Global Healthcare Gateway®. Formed in November 2020.
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08

Aus. Peptide Conference
Not Confirmed
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Aus. Peptide Conference
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Velpatasvir

About the Company : Zydus is headquartered in Ahmedabad, India, and ranks 4th in the Indian pharmaceutical industry. The group has manufacturing sites and research facilities spread across five states...

Zydus is headquartered in Ahmedabad, India, and ranks 4th in the Indian pharmaceutical industry. The group has manufacturing sites and research facilities spread across five states of Gujarat, Maharashtra, Goa, Himachal Pradesh and Sikkim in India and in the US and Brazil. Zydus’ global business has a strong presence in the regulated markets of the US, Europe (France and Spain) and in the high profile markets of Latin America and South Africa. It is also present in a big way in 25 other emerging markets worldwide.
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API Reference Price

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15-Mar-2022
22-Aug-2025
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ABOUT THIS PAGE

Looking for 1377049-84-7 / Velpatasvir API manufacturers, exporters & distributors?

Velpatasvir manufacturers, exporters & distributors 1

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

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

API | Excipient name

Velpatasvir

Synonyms

1377049-84-7, Gs-5816, Gs5816, Kcu0c7rs7z, Gs 5816, Methyl ((r)-2-((2s,4s)-2-(5-(2-((2s,5s)-1-((methoxycarbonyl)-l-valyl)-5-methylpyrrolidin-2-yl)-1,11-dihydroisochromeno[4',3':6,7]naphtho[1,2-d]imidazol-9-yl)-1h-imidazol-2-yl)-4-(methoxymethyl)pyrrolidin-1-yl)-2-oxo-1-phenylethyl)carbamate

Cas Number

1377049-84-7

Unique Ingredient Identifier (UNII)

KCU0C7RS7Z

About Velpatasvir

Velpatasvir is an orally available inhibitor of the hepatitis C virus (HCV) non-structural protein 5A (NS5A) replication complex, with potential activity against HCV genotypes 1-6. Although the exact mechanism of action of velpatasvir has not yet been completely determined, upon oral administration and intracellular uptake, it appears to bind to domain I of the NS5A protein. This inhibits the activity of the NS5A protein and results in the disruption of the viral RNA replication complex, blockage of viral HCV RNA production, and inhibition of viral replication. NS5A, a zinc-binding and proline-rich hydrophilic phosphoprotein, plays a crucial role in HCV RNA replication. HCV is a small, enveloped, single-stranded RNA virus belonging to the Flaviviridae family.

Velpatasvir Manufacturers

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

Velpatasvir Suppliers

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

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

Velpatasvir KDMF

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

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

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

click here to find a list of Velpatasvir suppliers with KDMF on PharmaCompass.

Velpatasvir WC

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

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

Velpatasvir 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 Velpatasvir as an active pharmaceutical ingredient (API).

Finished drug products

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

click here to find a list of Velpatasvir suppliers with NDC on PharmaCompass.

Velpatasvir GMP

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

Velpatasvir CoA

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

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

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