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Chemistry

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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 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 Formula	C₄₀H₅₀N₈O₆
Molecular Weight	738.9 g/mol
XLogP3	5.1
Hydrogen Bond Donor Count	4
Hydrogen Bond Acceptor Count	8
Rotatable Bond Count	13
Exact Mass	738.38533134 g/mol
Monoisotopic Mass	738.38533134 g/mol
Topological Polar Surface Area	175 Å²
Heavy Atom Count	54
Formal Charge	0
Complexity	1190
Isotope Atom Count	0
Defined Atom Stereocenter Count	4
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	1

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 : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...

LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, analytical method development and testing, and commercial manufacturing. LGM Pharma offers custom API synthesis, analytical development, and regulatory services. With a network of over 300 accredited CGMP manufacturing partners, LGM provides unparalleled supply chain security. And, with over 100,000 square feet of FDA-inspected cGMP manufacturing and warehouse capacity, LGM Pharma provides a one-stop solution for solid dose, powder, semi-solid and liquid drugs.

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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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HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It offers services such as sourcing, manufacturing & supply, helping partners enter new markets worldwide. Its strong partnerships with major players in the pharma and food additive industries help HRV Global effectively promote projects and products. HRV Global represents over 30 large Indian drugmakers, primarily targeting Europe, the US & the Middle East markets. Headquartered in India, HRV Global has offices in the US, Switzerland, Dubai, Lithuania & Turkey.

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API Reference Price

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AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2021","qtr":"Q4","strtotime":1639938600,"product":"DACLATASVIR DIHYDROCHLORIDE","address":"PLOTNO21JAWAHARLAL NEHRU PHARMACIT Y,PARAWADA","city":"VISAKHAPATNAM,ANDHRA PRADESH","supplier":"LAURUS LABS","supplierCountry":"INDIA","foreign_port":"SHEREMETYEVO","customer":"JSC PHARMSTANDARD LEKSREDSTVA","customerCountry":"RUSSIA","quantity":"40.00","actualQuantity":"40","unit":"KGS","unitRateFc":"1800","totalValueFC":"71699.3","currency":"USD","unitRateINR":135200,"date":"20-Dec-2021","totalValueINR":"5408000","totalValueInUsd":"71699.3","indian_port":"HYDERABAD AIR","hs_no":"29349990","bill_no":"6868139","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"RUSSIA","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"PLOTNO21JAWAHARLAL NEHRU PHARMACIT Y,PARAWADA, VISAKHAPATNAM,ANDHRA PRADESH","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":"Q2","strtotime":1712860200,"product":"DACLATASVIR DIHYDROCHLORIDE","address":"2ND FLOOR, SERENE CHAMBERS,","city":"","supplier":"LAURUS LABS","supplierCountry":"INDIA","foreign_port":"SHEREMETYEVO","customer":"JSC PHARMSTANDARD","customerCountry":"RUSSIA","quantity":"60.00","actualQuantity":"60","unit":"KGS","unitRateFc":"1800","totalValueFC":"106577.8","currency":"USD","unitRateINR":148333.74083333332,"date":"12-Apr-2024","totalValueINR":"8900024.45","totalValueInUsd":"106577.8","indian_port":"Hyderabad Air","hs_no":"29349990","bill_no":"9084915","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"RUSSIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"2ND FLOOR, SERENE CHAMBERS,, ","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":"Q4","strtotime":1728498600,"product":"DACLATASVIR DIHYDROCHLORIDE","address":"48,49,50,209,210 211.PHASE-II","city":"N\/A","supplier":"ARENE LIFE SCIENCES PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"MOSCOW DOMODEDOVO","customer":"JSC PHS-LEKSREDSTVA","customerCountry":"RUSSIA","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"135000","totalValueFC":"2626.9","currency":"INR","unitRateINR":110363.375,"date":"10-Oct-2024","totalValueINR":"220726.75","totalValueInUsd":"2626.9","indian_port":"Hyderabad Air","hs_no":"29420090","bill_no":"4735342","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":"","year":"2022","qtr":"Q1","strtotime":1642962600,"product":"DACLATASVIR DIHYDROCHLORIDE","address":"26, MANOJ INDUSTRIAL ESTATE, G.D. AMBEKAR MARG, WADALA","city":"MUMBAI, MAHARASHTRA","supplier":"ZHEJIANG CHEMICALS I & E CORP","supplierCountry":"CHINA","foreign_port":"#N\/A","customer":"FREDUN PHARMACEUTICALS LTD","customerCountry":"INDIA","quantity":"3.00","actualQuantity":"3","unit":"KGS","unitRateFc":"600","totalValueFC":"1819.5","currency":"USD","unitRateINR":"45180","date":"24-Jan-2022","totalValueINR":"135540","totalValueInUsd":"1819.5","indian_port":"BOMBAY AIR","hs_no":"29420090","bill_no":"7205051","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"#N\/A","supplierAddress":"","customerAddress":"26, MANOJ INDUSTRIAL ESTATE, G.D. AMBEKAR MARG, WADALA"}]

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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INTERMEDIATES SUPPLIERS

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FDF Dossiers

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FDA Orange Book

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Europe

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Listed Dossiers

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET;ORAL - EQ 30MG BASE

USFDA APPLICATION NUMBER - 206843

DOSAGE - TABLET;ORAL - EQ 60MG BASE

USFDA APPLICATION NUMBER - 206843

DOSAGE - TABLET;ORAL - EQ 90MG BASE

USFDA APPLICATION NUMBER - 206843

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Excipients by Applications

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Coating Systems & Additives

Fillers, Diluents & Binders

Controlled & Modified Release

Direct Compression

Disintegrants & Superdisintegrants

Thickeners and Stabilizers

Lubricants & Glidants

Granulation

Co-Processed Excipients

Film Formers & Plasticizers

Empty Capsules

Emulsifying Agents

Rheology Modifiers

Vegetarian Capsules

API Stability Enhancers

Taste Masking

Coloring Agents

Chewable & Orodispersible Aids

Topical

Parenteral

Surfactant & Foaming Agents

Solubilizers

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DATA COMPILATION #PharmaFlow

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Finished Drug Prices

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APIs

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Patents & EXCLUSIVITIES

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

27 API Suppliers

5 USDMF

5 EU WC

5 NDC API

22 Listed Suppliers

$ API Reference Price

INTERMEDIATES

9 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

12 FDF Dossiers

3 FDA Orange Book

6 Europe

3 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 30MG BASE

TABLET;ORAL - EQ 60MG BASE

TABLET;ORAL - EQ 90MG BASE

RELATED EXCIPIENT COMPANIES

1 SPI Pharma

3 DKSH

1 Jai Radhe Sales

2 Faran Shimi Pharmaceutical

7 Gangwal Healthcare

1 Nanjing Well Pharmaceutical

1 ACG Worldwide

6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 Clariant

10 Corel Pharma Chem

4 DFE Pharma

6 Gangwal Chemicals

5 Ideal Cures Pvt Ltd

1 Ingredion Pharma Solutions

21 Kerry

3 Kima Chemical

6 Lonza Capsugel

9 Microlex e.U

1 Novo Excipients

1 Pharmatrans-Sanaq

2 Pluviaendo

3 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

10 Roquette

6 Seppic

4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

9 Sigachi Industries

2 The Dow Chemical Company

3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

44 Coating Systems & Additives

31 Fillers, Diluents & Binders

20 Controlled & Modified Release

17 Direct Compression

15 Disintegrants & Superdisintegrants

13 Thickeners and Stabilizers

11 Lubricants & Glidants

10 Granulation

9 Co-Processed Excipients

8 Film Formers & Plasticizers

5 Empty Capsules

4 Emulsifying Agents

4 Rheology Modifiers

4 Vegetarian Capsules

4 API Stability Enhancers

4 Taste Masking

4 Coloring Agents

3 Chewable & Orodispersible Aids

2 Topical

1 Parenteral

1 Surfactant & Foaming Agents

1 Solubilizers

DIGITAL CONTENT

3 DATA COMPILATION #PharmaFlow

44 NEWS #PharmaBuzz