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Also known as: 1009119-64-5, Daclatasvir (bms-790052), Bms-790052, Daklinza, 1214735-16-6, Ebp 883
Molecular Formula
C40H50N8O6
Molecular Weight
738.9  g/mol
InChI Key
FKRSSPOQAMALKA-CUPIEXAXSA-N
FDA UNII
LI2427F9CI

Daclatasvir
Daclatasvir is an orally available inhibitor of the hepatitis C virus (HCV) non-structural protein 5A (NS5A) replication complex, with potential activity against HCV. Although the exact mechanism of action of daclatasvir has yet to be fully determined, this agent, upon oral administration and after intracellular uptake, 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.
Daclatasvir is a Hepatitis C Virus NS5A Inhibitor. The mechanism of action of daclatasvir is as a P-Glycoprotein Inhibitor, and Organic Anion Transporting Polypeptide 1B1 Inhibitor, and Organic Anion Transporting Polypeptide 1B3 Inhibitor, and Breast Cancer Resistance Protein Inhibitor.
1 2D Structure

Daclatasvir

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
methyl N-[(2S)-1-[(2S)-2-[5-[4-[4-[2-[(2S)-1-[(2S)-2-(methoxycarbonylamino)-3-methylbutanoyl]pyrrolidin-2-yl]-1H-imidazol-5-yl]phenyl]phenyl]-1H-imidazol-2-yl]pyrrolidin-1-yl]-3-methyl-1-oxobutan-2-yl]carbamate
2.1.2 InChI
InChI=1S/C40H50N8O6/c1-23(2)33(45-39(51)53-5)37(49)47-19-7-9-31(47)35-41-21-29(43-35)27-15-11-25(12-16-27)26-13-17-28(18-14-26)30-22-42-36(44-30)32-10-8-20-48(32)38(50)34(24(3)4)46-40(52)54-6/h11-18,21-24,31-34H,7-10,19-20H2,1-6H3,(H,41,43)(H,42,44)(H,45,51)(H,46,52)/t31-,32-,33-,34-/m0/s1
2.1.3 InChI Key
FKRSSPOQAMALKA-CUPIEXAXSA-N
2.1.4 Canonical SMILES
CC(C)C(C(=O)N1CCCC1C2=NC=C(N2)C3=CC=C(C=C3)C4=CC=C(C=C4)C5=CN=C(N5)C6CCCN6C(=O)C(C(C)C)NC(=O)OC)NC(=O)OC
2.1.5 Isomeric SMILES
CC(C)[C@@H](C(=O)N1CCC[C@H]1C2=NC=C(N2)C3=CC=C(C=C3)C4=CC=C(C=C4)C5=CN=C(N5)[C@@H]6CCCN6C(=O)[C@H](C(C)C)NC(=O)OC)NC(=O)OC
2.2 Other Identifiers
2.2.1 UNII
LI2427F9CI
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Bms-790052

2. Bms-790052-05

3. Carbamic Acid, N,n'-((1,1'-biphenyl)-4,4'-diylbis(1h-imidazole-5,2-diyl-(2s)-2,1-pyrrolidinediyl((1s)-1-(1-methylethyl)-2-oxo-2,1-ethanediyl)))bis-, C,c'-dimethyl Ester

4. Daclatasvir Dihydrochloride

5. Daklinza

2.3.2 Depositor-Supplied Synonyms

1. 1009119-64-5

2. Daclatasvir (bms-790052)

3. Bms-790052

4. Daklinza

5. 1214735-16-6

6. Ebp 883

7. Bms790052

8. Bms 790052

9. Daclatasvir [usan]

10. Methyl N-[(2s)-1-[(2s)-2-[5-[4-[4-[2-[(2s)-1-[(2s)-2-(methoxycarbonylamino)-3-methylbutanoyl]pyrrolidin-2-yl]-1h-imidazol-5-yl]phenyl]phenyl]-1h-imidazol-2-yl]pyrrolidin-1-yl]-3-methyl-1-oxobutan-2-yl]carbamate

11. Chebi:82977

12. Ebp-883

13. Daclatasvir (usan)

14. Carbamic Acid, N,n'-[[1,1'-biphenyl]-4,4'-diylbis[1h-imidazole-5,2-diyl-(2s)-2,1-pyrrolidinediyl[(1s)-1-(1-methylethyl)-2-oxo-2,1-ethanediyl]]]bis-, C,c'-dimethyl Ester

15. Carbamic Acid, N,n'-((1,1'-biphenyl)-4,4'-diylbis(1h-imidazole-5,2-diyl-(2s)-2,1-pyrrolidinediyl((1s)-1-(1-methylethyl)-2-oxo-2,1-ethanediyl)))bis-, C,c'-dimethyl Ester

16. Dimethyl ((2s,2's)-((2s,2's)-2,2'-(5,5'-([1,1'-biphenyl]-4,4'-diyl)bis(1h-imidazole-5,2-diyl))bis(pyrrolidine-2,1-diyl))bis(3-methyl-1-oxobutane-2,1-diyl))dica

17. 1009119-65-6

18. Li2427f9ci

19. Methyl N-[(1s)-1-[(2s)-2-[5-[4-[4-[2-[(2s)-1-[(2s)-2-(methoxycarbonylamino)-3-methyl-butanoyl]pyrrolidin-2-yl]-1h-imidazol-5-yl]phenyl]phenyl]-1h-imidazol-2-yl]pyrrolidine-1-carbonyl]-2-methyl-propyl]carbamate

20. Daclatasvir [mi]

21. Daclatasvir [inn]

22. Daclatasvir [who-dd]

23. Dimethyl (2s,2's)-1,1'-((2s,2's)-2,2'-(4,4'-(biphenyl-4,4'-diyl)bis(1h-imidazole-4,2-diyl))bis(pyrrolidine-2,1-diyl))bis(3-methyl-1-oxobutane-2,1-diyl)dicarbamate

24. Mls006011140

25. Ebp883

26. Schembl2756027

27. Chembl2023898

28. Schembl17897804

29. Gtpl11266

30. Ex-a410

31. Dtxsid901026404

32. Amy36655

33. Dimethyl ((2s,2's)-((2s,2's)-2,2'-(5,5'-([1,1'-biphenyl]-4,4'-diyl)bis(1h-imidazole-5,2-diyl))bis(pyrrolidine-2,1-diyl))bis(3-methyl-1-oxobutane-2,1-diyl))dicarbamate

34. Dimethyl N,n'-(biphenyl-4,4'-diylbis{1h-imidazole-5,2-diyl-((2s)-pyrrolidine-2,1- Diyl)((1s)-1-(1-methylethyl)-2-oxoethane-2,1-diyl)})dicarbamate

35. Bdbm50387084

36. Mfcd17129086

37. S1482

38. Zinc68204830

39. Ccg-270425

40. Cs-0588

41. Db09102

42. Ncgc00346533-07

43. Ncgc00346533-09

44. Ac-28958

45. As-75298

46. Hy-10466

47. Smr004702917

48. Sw219754-1

49. D10065

50. J-520204

51. Q5207712

52. Dimethyl N,n'-((1,1'-biphenyl)-4,4'-diylbis(1h-imidazole-5,2-diyl-((2s)-pyrrolidine-2,1-diyl)((1s)-3-methyl-1-oxobutane-1,2-diyl)))dicarbamate

53. Methyl ((s)-1-((s)-2-(5-(4'-(2-((s)-1-((methoxycarbonyl)-l-valyl)pyrrolidin-2-yl)-1h-imidazol-5-yl)-[1,1'-biphenyl]-4-yl)-1h-imidazol-2-yl)pyrrolidin-1-yl)-3-methyl-1-oxobutan-2-yl)carbamate

54. Methyl [(2s)-1-{(2s)-2-[4-(4'-{2-[(2s)-1-{(2s)-2-[(methoxycarbonyl)amino]-3-methylbutanoyl}-2-pyrrolidinyl]-1h-imidazol-4-yl}-4-biphenylyl)-1h-imidazol-2-yl]-1-pyrrolidinyl}-3-methyl-1-oxo-2-butanyl]carbamate

55. Methyl [(2s)-1-{(2s)-2-[4-(4'-{2-[(2s)-1-{(2s)-2-[(methoxycarbonyl)amino]-3-methylbutanoyl}pyrrolidin-2-yl]-1h-imidazol-4-yl}biphenyl-4-yl)-1h-imidazol-2-yl]pyrrolidin-1-yl}-3-methyl-1-oxobutan-2-yl]carbamate

56. Methyl [(2s)-1-{(2s)-2-[5-(4'-{2-[(2s)-1-{(2s)-2-[(methoxycarbonyl)amino]-3-methylbutanoyl}pyrrolidin-2-yl]-1h-imidazol-5-yl}biphenyl-4-yl)-1h-imidazol-2-yl]pyrrolidin-1-yl}-3-methyl-1-oxobutan-2-yl]carbamate

57. Methyl N-[(2s)-1-[(2s)-2-[5-(4'-{2-[(2s)-1-[(2s)-2-[(methoxycarbonyl)amino]-3-methylbutanoyl]pyrrolidin-2-yl]-1h-imidazol-5-yl}-[1,1'-biphenyl]-4-yl)-1h-imidazol-2-yl]pyrrolidin-1-yl]-3-methyl-1-oxobutan-2-yl]carbamate

58. Methyl-n-[(2s)-1-[(2s)-2-[5-[4-[4-[2-[(2s)-1-[(2s)-2-(methoxycarbonylamino)-3-methylbutanoyl] Pyrrolidin-2-yl]-1h-imidazol-5-yl]phenyl]phenyl]-1himidazol-2-yl]pyrrolidin-1-yl]3-methyl-1-oxobutan-2-yl]carbamate

2.4 Create Date
2009-02-23
3 Chemical and Physical Properties
Molecular Weight 738.9 g/mol
Molecular Formula C40H50N8O6
XLogP35.1
Hydrogen Bond Donor Count4
Hydrogen Bond Acceptor Count8
Rotatable Bond Count13
Exact Mass738.38533134 g/mol
Monoisotopic Mass738.38533134 g/mol
Topological Polar Surface Area175 Ų
Heavy Atom Count54
Formal Charge0
Complexity1190
Isotope Atom Count0
Defined Atom Stereocenter Count4
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Indication

Indicated for use with sofosbuvir, with or without ribavirin, for the treatment of chronic HCV genotype 1a/b or 3 infection. The dosing regimen of 60mg daclatasvir 60 mg with 400mg sofosbuvir once a day is recommended for both genontypes. Resistance: Reduced susceptibility to daclatasvir was associated with the polymorphisms at NS5A amino acid positions M28, Q30, L31, and Y93 in genotypes 1a, 1b, and 3a patients. NS5A Resistance Testing is recommended for HCV genotype 1a-infected patients with cirrhosis prior to the initiaition of the treatment, as the risk of resistance development is higher in genotype 1a patients.


FDA Label


Daklinza is indicated in combination with other medicinal products for the treatment of chronic hepatitis C virus (HCV) infection in adults (see sections 4. 2, 4. 4 and 5. 1).

For HCV genotype specific activity, see sections 4. 4 and 5. 1.


5 Pharmacology and Biochemistry
5.1 Pharmacology

Daclatasvir is a direct-acting antiviral agent that targets the NS5A and causes a decrease in serum HCV RNA levels. It disrupts HCV replication by specifically inhibiting the critical functions of an NS5A protein in the replication complex. It is shown to cause downregulation of the hyperphosphorylation of NS5A. It does not appear to prolong the QT interval even when given at 3 times the maximum recommended dose.


5.2 FDA Pharmacological Classification
5.2.1 Active Moiety
DACLATASVIR
5.2.2 FDA UNII
LI2427F9CI
5.2.3 Pharmacological Classes
Mechanisms of Action [MoA] - Breast Cancer Resistance Protein Inhibitors
5.3 ATC Code

J05AP07


J - Antiinfectives for systemic use

J05 - Antivirals for systemic use

J05A - Direct acting antivirals

J05AP - Antivirals for treatment of hcv infections

J05AP07 - Daclatasvir


5.4 Absorption, Distribution and Excretion

Absorption

Studies demonstrated that peak plasma concentrations typically occurred within 2 hours after administration of multiple oral doses ranging from 1 - 100 mg once daily. Steady state is reached after approximately 4 days of once-daily daclatasvir administration. The absolute bioavailability of the tablet formulation is 67%.


Route of Elimination

Approximately 88% of total dose of daclatasvir is eliminated into bile and feces in which 53% remains as unchanged form, while 6.6% of the total dose is eliminated primarily unchanged in the urine.


Volume of Distribution

The approximate volume of distribution of daclatasvir is 47 L in patients who was orally administered 60 mg tablet followed by 100 g [13C,15N]-daclatasvir intravenously.


Clearance

In subjects who received daclatasvir 60 mg tablet orally followed by 100 g radiolabeled daclatasvir intravenously, the total clearance was 4.2 L/h.


5.5 Metabolism/Metabolites

Daclastavir is a substrate of CYP3A enzymes where its metabolism is predominantly mediated by CYP3A4 isoform. Oxidative pathways included -oxidation of the pyrrolidine moiety, resulting in ring opening to an aminoaldehyde intermediate followed by an intramolecular reaction between the aldehyde and the proximal imidazole nitrogen atom. High proportion of the drug in the plasma (greater than 97%) is in the unchanged form.


5.6 Biological Half-Life

Following multiple dose administration of daclatasvir in HCV-infected subjects, with doses ranging from 1 mg to 100 mg once daily, the terminal elimination half-life of daclatasvir ranged from approximately 12 to 15 hours.


5.7 Mechanism of Action

NS5A is a viral nonstructural phospoprotein that is part of a functional replication complex in charge of viral RNA genome amplification on endoplasmic reticulum membranes. It has the ability to bind to HCV RNA. It is shown to have two distinct functions in HCV RNA replication based on phosphorylated states. Maintaining the HCV replication complex is mediated by the cis-acting function of basally phosphorylated NS5A and the trans-acting function of hyperphosphorylated NS5A modulates HCV assembly and infectious particle formation. Daclatasvir is shown to disrupt hyperphosphorylated NS5A proteins thus interfere with the function of new HCV replication complexes. It is also reported that daclatasvir also blocks both intracellular viral RNA synthesis and virion assembly/secretion in vivo.


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About the Company : Synergene Active Ingredients Pvt.Ltd was incorporated in 2006 and commercial operations began in the same year. The Company is a manufacturer and supplier of Active Pharmaceuticals...

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Daclatasvir

About the Company : Viruj Pharmaceuticals, an India-based company with a global presence, aims to develop & market complex, technology-driven APIs. It offers contract API manufacturing for innovative ...

Viruj Pharmaceuticals, an India-based company with a global presence, aims to develop & market complex, technology-driven APIs. It offers contract API manufacturing for innovative companies globally, & APIs for generic companies. Viruj Pharmaceuticals adheres to quality systems defined in Schedule M, Schedule L, ICH Q7 & TRS guidelines & leads in process validation, cleaning validation, analytical method transfers & process technology. It ensures GMP compliance at its facility. Viruj seeks to develop APIs via continuous Flow Technology & has invested in the requisite infrastructure for developing APIs using Flow Chemistry techniques.
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API Reference Price

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[{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1653503400,"product":"DACLATASVIR DIHYDROCHLORIDE IN-HOUSE","address":"H.NO.4-7-101, SCIENTIST COLONY, HABSIGUDA, NACHARAM, Contact No: 91","city":"HYDERABAD","supplier":"OPTIMUS DRUGS PRIVATE ","supplierCountry":"INDIA","foreign_port":"CAIRO","customer":"M\/S.TO THE ORDER OF","customerCountry":"EGYPT","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"300","totalValueFC":"7310.5","currency":"USD","unitRateINR":22600,"date":"26-May-2022","totalValueINR":"565000","totalValueInUsd":"7310.5","indian_port":"HYDERABAD AIR","hs_no":"29349990","bill_no":"1660353","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"EGYPT","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"H.NO.4-7-101, SCIENTIST COLONY, HABSIGUDA, NACHARAM, Contact No: 91, HYDERABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1678300200,"product":"DACLATASVIR DI HYDROCHLORIDE (TAX NO.VOL","address":"FLAT NO.202, RAJ APARTMENT,RAJEEV NAGAR","city":"HYDERABAD,TELANGANA","supplier":"VIRUPAKSHA ORGANICS","supplierCountry":"INDIA","foreign_port":"KARACHI -","customer":"MEDISURE LABORATORIES PAKISTAN","customerCountry":"PAKISTAN","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"650","totalValueFC":"559.3","currency":"USD","unitRateINR":46000,"date":"09-Mar-2023","totalValueINR":"46000","totalValueInUsd":"559.3","indian_port":"HYDERABAD AIR","hs_no":"29349990","bill_no":"8333824","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"PAKISTAN","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"FLAT NO.202, RAJ APARTMENT,RAJEEV NAGAR, HYDERABAD,TELANGANA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1681151400,"product":"DACLATASVIR DI HYDROCHLORIDE","address":"B-4, IDA,","city":"HYDERABAD, TELANGANA.","supplier":"VIRUPAKSHA ORGANICS","supplierCountry":"INDIA","foreign_port":"ISLAMABAD","customer":"FERZSONS LABORATORIES LTD","customerCountry":"PAKISTAN","quantity":"32.00","actualQuantity":"32","unit":"KGS","unitRateFc":"433.8","totalValueFC":"13735.4","currency":"USD","unitRateINR":35177.125,"date":"11-Apr-2023","totalValueINR":"1125668","totalValueInUsd":"13735.4","indian_port":"ARSHIYA-SEZ\/PANVEL","hs_no":"29349990","bill_no":"4000663","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"PAKISTAN","selfForZScoreResived":"Pharma Grade","supplierPort":"ARSHIYA-SEZ\/PANVEL","supplierAddress":"B-4, IDA,, HYDERABAD, TELANGANA.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1689791400,"product":"DACLATASVIR DIHYDROCHLORIDE (TAX INV NO.","address":"FLAT NO.202, RAJ APARTMENT,RAJEEV NAGAR","city":"HYDERABAD,TELANGANA","supplier":"VIRUPAKSHA ORGANICS","supplierCountry":"INDIA","foreign_port":"ISLAMABAD - ISLAMABA","customer":"MCB BANK LIMITED","customerCountry":"PAKISTAN","quantity":"105.00","actualQuantity":"105","unit":"KGS","unitRateFc":"440","totalValueFC":"45468.1","currency":"USD","unitRateINR":35590.479599999999,"date":"20-Jul-2023","totalValueINR":"3737000.358","totalValueInUsd":"45468.1","indian_port":"HYDERABAD AIR","hs_no":"29332990","bill_no":"0","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"PAKISTAN","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"FLAT NO.202, RAJ APARTMENT,RAJEEV NAGAR, HYDERABAD,TELANGANA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1696876200,"product":"DACLATASVIR DIHYDROCHLORIDE IN-HOUSE PHARMACEUTICAL FOR PHARMACEUTICAL RAW MATERIAL AS PER PO","address":"PLOT NO.131,3RD FLOOR,NARMADA","city":"HYDERABAD. AP","supplier":"OPTIMUS DRUGS PRIVATE ","supplierCountry":"INDIA","foreign_port":"CAIRO","customer":"TO THE ORDER OF","customerCountry":"EGYPT","quantity":"350.00","actualQuantity":"350","unit":"KGS","unitRateFc":"700","totalValueFC":"242198.4","currency":"USD","unitRateINR":57594.285714285717,"date":"10-Oct-2023","totalValueINR":"20158000","totalValueInUsd":"242198.4","indian_port":"Hyderabad Air","hs_no":"29349990","bill_no":"4528823","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"EGYPT","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"PLOT NO.131,3RD FLOOR,NARMADA, HYDERABAD. AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1726857000,"product":"DACLATASVIR DIHYDROCHLORIDE TECHNICAL , CAS NO. 1009119-65-6, BATCH NOS. 41230924001 , 41230924002 MFG DATE S","address":"S. NO. 136\/11,,GAURA VADDO, CALANG","city":"CALANGUTE,GOA","supplier":"SADAR BIOTECH PRIVATE ","supplierCountry":"INDIA","foreign_port":"MOSCOW","customer":"TO THE ORDER","customerCountry":"RUSSIA","quantity":"129.00","actualQuantity":"129","unit":"KGS","unitRateFc":"99396","totalValueFC":"153005.9","currency":"INR","unitRateINR":99396.001705426359,"date":"21-Sep-2024","totalValueINR":"12822084.22","totalValueInUsd":"153005.9","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"4235089","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"RUSSIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"S. NO. 136\/11,,GAURA VADDO, CALANG, CALANGUTE,GOA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1727029800,"product":"DACLATASVIR DIHYDROCHLORIDE TECHNICAL","address":"S. NO. 136\/11,,GAURA VADDO, CALANG","city":"CALANGUTE,GOA","supplier":"SADAR BIOTECH PRIVATE ","supplierCountry":"INDIA","foreign_port":"MOSCOW","customer":"TO THE ORDER ,","customerCountry":"RUSSIA","quantity":"129.00","actualQuantity":"129","unit":"KGS","unitRateFc":"99396","totalValueFC":"153005.9","currency":"INR","unitRateINR":99396.001705426359,"date":"23-Sep-2024","totalValueINR":"12822084.22","totalValueInUsd":"153005.9","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"4275880","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"RUSSIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"S. NO. 136\/11,,GAURA VADDO, CALANG, CALANGUTE,GOA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729794600,"product":"DACLATASVIR DIHYDROCHLORIDE","address":"FLAT.203,SATYA SAI RESY.PLOT","city":"ROAD,AMEERPET, HYDERABAD,AP","supplier":"NIFTY LABS","supplierCountry":"INDIA","foreign_port":"MOSCOW","customer":"M\/S.PHS-LEKSREDSTVA JSC","customerCountry":"RUSSIA","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"900","totalValueFC":"1722.8","currency":"USD","unitRateINR":72380,"date":"25-Oct-2024","totalValueINR":"144760","totalValueInUsd":"1722.8","indian_port":"Hyderabad Air","hs_no":"29332990","bill_no":"5115776","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"RUSSIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"FLAT.203,SATYA SAI RESY.PLOT, ROAD,AMEERPET, HYDERABAD,AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1730917800,"product":"DACLATASVIR DIHYDROCHLORIDE TECHNICAL (GST INVOICE NO:U1\/24-25\/EXP\/131 DT:31\/10\/2024)","address":"48,49,50,209,210 211.PHASE-II","city":"N\/A","supplier":"ARENE LIFE SCIENCES PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"SHEREMETYEVO","customer":"JSC PHARMSTANDARD","customerCountry":"RUSSIA","quantity":"97.00","actualQuantity":"97","unit":"KGS","unitRateFc":"74000","totalValueFC":"78193","currency":"INR","unitRateINR":68026.420824742265,"date":"07-Nov-2024","totalValueINR":"6598562.82","totalValueInUsd":"78193","indian_port":"Hyderabad Air","hs_no":"29420090","bill_no":"5415801","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"RUSSIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"48,49,50,209,210 211.PHASE-II, N\/A","customerAddress":""},{"dataSource":"API Import","activeIngredients":"DACLATASVIR DIHYDROCHLORIDE","year":"2021","qtr":"Q1","strtotime":1609439400,"product":"DACLATASVIR DIHYDROCHLORIDE","address":"26, MANOJ INDUSTRIAL ESTATE,G.D. AMBEKAR MARG, WADALA","city":"MUMBAI, MAHARASHTRA","supplier":"HANGZHOU YAXIN PHARMACEUTICAL ","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"FREDUN PHARMACEUTICALS LTD.","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"700","totalValueFC":"712.6","currency":"USD","unitRateINR":"52115","date":"01-Jan-2021","totalValueINR":"52115","totalValueInUsd":"712.6","indian_port":"BOMBAY AIR","hs_no":"29420090","bill_no":"2200067","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"","customerAddress":"26, MANOJ INDUSTRIAL ESTATE,G.D. AMBEKAR MARG, WADALA"}]
01-Jan-2021
07-Nov-2024
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INTERMEDIATE SUPPLIERS

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01

PMC Isochem

France
World ADC London
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  • fda
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  • WHO-GMP

Virtual BoothPMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.

CAS Number : 74761-42-5

End Use API : Daclatasvir

About The Company : PMC Isochem is a CDMO company acquired by PMC International in 2017. It manufactures cGMP intermediates, active pharmaceutical ingredients and functional excipi...

PMC Isochem

02

World ADC London
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World ADC London
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CAS Number : 4072-67-7

End Use API : Daclatasvir

About The Company : Established in 2011 and situated in Hangzhou, Zhejiang, China, Hangzhou Longshine Bio-Tech CO., Ltd is dedicated to providing services for pharmaceutical and ch...

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03

World ADC London
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CAS Number : 74761-42-5

End Use API : Daclatasvir

About The Company : Established in 2011 and situated in Hangzhou, Zhejiang, China, Hangzhou Longshine Bio-Tech CO., Ltd is dedicated to providing services for pharmaceutical and ch...

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04

World ADC London
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World ADC London
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CAS Number : 4072-67-7

End Use API : Daclatasvir

About The Company : Jiangsu Yutian Pharmaceutical Co., Ltd. is located in Dapu Pharmaceutical Zone of Lianyungang City in Jiangsu Province. It is a new and high-tech enterprise eng...

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05

World ADC London
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CAS Number : 1009119-83-8

End Use API : Daclatasvir

About The Company : Jiangsu Yutian Pharmaceutical Co., Ltd. is located in Dapu Pharmaceutical Zone of Lianyungang City in Jiangsu Province. It is a new and high-tech enterprise eng...

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06

World ADC London
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World ADC London
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CAS Number : 4072-67-7

End Use API : Daclatasvir

About The Company : Prajna is an innovation driven pharmaceutical company. We dedicated to Research, Process development and Manufacturing APIs and Advanced Intermediates for Activ...

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07

World ADC London
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World ADC London
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CAS Number : 1009119-83-8

End Use API : Daclatasvir

About The Company : Prajna is an innovation driven pharmaceutical company. We dedicated to Research, Process development and Manufacturing APIs and Advanced Intermediates for Activ...

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FDF Dossiers

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01

World ADC London
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DACLATASVIR DIHYDROCHLORIDE

Brand Name : DAKLINZA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 60MG BASE

Packaging :

Approval Date : 2015-07-24

Application Number : 206843

Regulatory Info : DISCN

Registration Country : USA

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02

World ADC London
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DACLATASVIR DIHYDROCHLORIDE

Brand Name : DAKLINZA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 90MG BASE

Packaging :

Approval Date : 2016-04-13

Application Number : 206843

Regulatory Info : DISCN

Registration Country : USA

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03

World ADC London
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daklatasvirdihydroklorid

Brand Name : Daklinza

Dosage Form : FILM COATED PILL

Dosage Strength : 30 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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04

World ADC London
Not Confirmed
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daklatasvirdihydroklorid

Brand Name : Daklinza

Dosage Form : FILM COATED PILL

Dosage Strength : 60 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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05

World ADC London
Not Confirmed
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daclatasvir

Brand Name : Daklinza

Dosage Form : Daclatasvir 30Mg 28 Combined Oral Use

Dosage Strength : 28 cpr riv 30 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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06

World ADC London
Not Confirmed
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daclatasvir

Brand Name : Daklinza

Dosage Form : Daclatasvir 60Mg 28 Combined Oral Use

Dosage Strength : 28 cpr riv 60 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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07

World ADC London
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daclatasvir

Brand Name : Daklinza

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 60 mg

Packaging : Calendar Gasket

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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08

World ADC London
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Daclatasvir

Brand Name :

Dosage Form : Tablet

Dosage Strength : 60MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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JV Pharmland

Belarus
World ADC London
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JV Pharmland

Belarus
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Not Confirmed

Daclatasvir

Brand Name :

Dosage Form : Tablet

Dosage Strength : 60MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Belarus

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10

World ADC London
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Daclatasvir

Brand Name : DACATEC

Dosage Form : Tablet

Dosage Strength : 60MG

Packaging : Jar pack of 30's

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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Listed Dossiers

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01

World ADC London
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Daclatasvir

Brand Name :

Dosage Form : Tablet

Dosage Strength : 60MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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01

World ADC London
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World ADC London
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Daclatasvir

Dosage : Tablet

Dosage Strength : 60MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

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02

JV Pharmland

Belarus
World ADC London
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JV Pharmland

Belarus
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Not Confirmed

Daclatasvir

Brand Name :

Dosage Form : Tablet

Dosage Strength : 60MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Belarus

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02

JV Pharmland

Belarus
World ADC London
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JV Pharmland

Belarus
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Not Confirmed

Daclatasvir

Dosage : Tablet

Dosage Strength : 60MG

Brand Name :

Approval Date :

Application Number :

Registration Country : Belarus

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03

World ADC London
Not Confirmed
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World ADC London
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Daclatasvir

Brand Name : DACATEC

Dosage Form : Tablet

Dosage Strength : 60MG

Packaging : Jar pack of 30's

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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03

World ADC London
Not Confirmed
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World ADC London
Not Confirmed

Daclatasvir

Dosage : Tablet

Dosage Strength : 60MG

Brand Name : DACATEC

Approval Date :

Application Number :

Registration Country : India

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04

World ADC London
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World ADC London
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Daclatasvir Dihydrochloride

Brand Name : Zacutas 90

Dosage Form : Tablet

Dosage Strength : 98.88MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Vietnam

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04

World ADC London
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World ADC London
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Daclatasvir Dihydrochloride

Dosage : Tablet

Dosage Strength : 98.88MG

Brand Name : Zacutas 90

Approval Date :

Application Number :

Registration Country : Vietnam

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05

World ADC London
Not Confirmed
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World ADC London
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Daclatasvir Dihydrochloride

Brand Name : Zacutas 60

Dosage Form : Tablet

Dosage Strength : 65.92MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Vietnam

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05

World ADC London
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Daclatasvir Dihydrochloride

Dosage : Tablet

Dosage Strength : 65.92MG

Brand Name : Zacutas 60

Approval Date :

Application Number :

Registration Country : Vietnam

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET;ORAL - EQ 30MG BASE

USFDA APPLICATION NUMBER - 206843

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DOSAGE - TABLET;ORAL - EQ 60MG BASE

USFDA APPLICATION NUMBER - 206843

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DOSAGE - TABLET;ORAL - EQ 90MG BASE

USFDA APPLICATION NUMBER - 206843

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ABOUT THIS PAGE

Looking for 1009119-64-5 / Daclatasvir API manufacturers, exporters & distributors?

Daclatasvir manufacturers, exporters & distributors 1

64

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

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Daclatasvir manufacturer or Daclatasvir supplier.

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

API | Excipient name

Daclatasvir

Synonyms

1009119-64-5, Daclatasvir (bms-790052), Bms-790052, Daklinza, 1214735-16-6, Ebp 883

Cas Number

1009119-64-5

Unique Ingredient Identifier (UNII)

LI2427F9CI

About Daclatasvir

Daclatasvir is an orally available inhibitor of the hepatitis C virus (HCV) non-structural protein 5A (NS5A) replication complex, with potential activity against HCV. Although the exact mechanism of action of daclatasvir has yet to be fully determined, this agent, upon oral administration and after intracellular uptake, 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.

Daclatasvir Manufacturers

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

Daclatasvir Suppliers

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

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

Daclatasvir USDMF

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

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

click here to find a list of Daclatasvir suppliers with USDMF on PharmaCompass.

Daclatasvir WC

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

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

Daclatasvir 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 Daclatasvir as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Daclatasvir GMP

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

Daclatasvir CoA

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

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

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