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Edoxaban Tosylate

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Also known as: 480449-70-5, 912273-65-5, Du-176, Du-176b, Ndu3j18apo, N1-(5-chloropyridin-2-yl)-n2-((1s,2r,4s)-4-(dimethylcarbamoyl)-2-(5-methyl-4,5,6,7-tetrahydrothiazolo[5,4-c]pyridine-2-carboxamido)cyclohexyl)oxalamide

Molecular Formula

C₂₄H₃₀ClN₇O₄S

Molecular Weight

548.1 g/mol

InChI Key

HGVDHZBSSITLCT-JLJPHGGASA-N

FDA UNII

NDU3J18APO

Edoxaban is an orally active inhibitor of coagulation factor Xa (activated factor X) with anticoagulant activity. Edoxaban is administered as edoxaban tosylate. This agent has an elimination half-life of 9-11 hours and undergoes renal excretion.

Edoxaban is a Factor Xa Inhibitor. The mechanism of action of edoxaban is as a Factor Xa Inhibitor.

1 2D Structure

Edoxaban Tosylate

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

N'-(5-chloropyridin-2-yl)-N-[(1S,2R,4S)-4-(dimethylcarbamoyl)-2-[(5-methyl-6,7-dihydro-4H-[1,3]thiazolo[5,4-c]pyridine-2-carbonyl)amino]cyclohexyl]oxamide

2.1.2 InChI

InChI=1S/C24H30ClN7O4S/c1-31(2)24(36)13-4-6-15(27-20(33)21(34)30-19-7-5-14(25)11-26-19)17(10-13)28-22(35)23-29-16-8-9-32(3)12-18(16)37-23/h5,7,11,13,15,17H,4,6,8-10,12H2,1-3H3,(H,27,33)(H,28,35)(H,26,30,34)/t13-,15-,17+/m0/s1

2.1.3 InChI Key

HGVDHZBSSITLCT-JLJPHGGASA-N

2.1.4 Canonical SMILES

CN1CCC2=C(C1)SC(=N2)C(=O)NC3CC(CCC3NC(=O)C(=O)NC4=NC=C(C=C4)Cl)C(=O)N(C)C

2.1.5 Isomeric SMILES

CN1CCC2=C(C1)SC(=N2)C(=O)N[C@@H]3C[C@H](CC[C@@H]3NC(=O)C(=O)NC4=NC=C(C=C4)Cl)C(=O)N(C)C

2.2 Other Identifiers

2.2.1 UNII

NDU3J18APO

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Du-176

2. Du-176b

3. Edoxaban Tosylate

4. N-(5-chloropyridin-2-yl)-n'-((1s,2r,4s)-4-(n,n-dimethylcarbamoyl)-2-(5-methyl-4,5,6,7- Tetrahydro(1,3)thiazolo(5,4-c)pyridine-2-carboxamido)cyclohexyl)oxamide

5. N-(5-chloropyridin-2-yl)-n'-((1s,2r,4s)-4-(n,n-dimethylcarbamoyl)-2-(5-methyl-4,5,6,7-tetrahydrothiazolo(5,4-c)pyridine-2-carboxamido)cyclohexyl)ethanediamide P-toluenesulfonate Monohydrate

6. Savaysa

2.3.2 Depositor-Supplied Synonyms

1. 480449-70-5

2. 912273-65-5

3. Du-176

4. Du-176b

5. Ndu3j18apo

6. N1-(5-chloropyridin-2-yl)-n2-((1s,2r,4s)-4-(dimethylcarbamoyl)-2-(5-methyl-4,5,6,7-tetrahydrothiazolo[5,4-c]pyridine-2-carboxamido)cyclohexyl)oxalamide

7. Chembl1269025

8. Chebi:85973

9. 480449-70-5 (free Base)

10. N-(5-chloropyridin-2-yl)-n'-((1s,2r,4s)-4-(n,n-dimethylcarbamoyl)-2-(5-methyl-4,5,6,7- Tetrahydro(1,3)thiazolo(5,4-c)pyridine-2-carboxamido)cyclohexyl)oxamide

11. Edoxaban [usan]

12. Ethanediamide, N1-(5-chloro-2-pyridinyl)-n2-((1s,2r,4s)-4- ((dimethylamino)carbonyl)- 2-(((4,5,6,7-tetrahydro-5-methylthiazolo(5,4-c)pyridin-2-yl)carbonyl)amino)cyclohexyl)-

13. Edoxaban [usan:inn]

14. Unii-ndu3j18apo

15. Edoxaban (usan/inn)

16. Edoxaban [inn]

17. Edoxaban [mi]

18. Edoxaban [mart.]

19. Edoxaban [who-dd]

20. Schembl330046

21. Amy508

22. Gtpl7575

23. Hsdb 8406

24. Dtxsid50197398

25. Ex-a5582

26. Bdbm50328731

27. Mfcd13195544

28. S4429

29. Zinc43200832

30. Akos005146069

31. Cs-1331

32. Db09075

33. Ncgc00378907-01

34. Ncgc00378907-02

35. Ncgc00378907-03

36. Ac-35419

37. As-35107

38. Hy-10264

39. N-(5-chloro-2-pyridinyl)-n'-[(1s,2r,4s)-4-[(dimethylamino)carbonyl]-2-[[(4,5,6,7-tetrahydro-5-methylthiazolo[5,4-c]pyridin-2-yl)carbonyl]amino]cyclohexyl]ethanediamide

40. D09710

41. 449e705

42. A860576

43. Q21011234

44. N'-(5-chloropyridin-2-yl)-n-[(1s,2r,4s)-4-(dimethylcarbamoyl)-2-[(5-methyl-6,7-dihydro-4h-[1,3]thiazolo[5,4-c]pyridine-2-carbonyl)amino]cyclohexyl]oxamide

45. N'-(5-chloropyridin-2-yl)-n-[(1s,2r,4s)-4-(dimethylcarbamoyl)-2-[(5-methyl6,7-dihydro-4h-[1,3]thiazolo[5,4-c]pyridine-2-carbonyl)amino]cyclohexyl]oxamide

46. N(1)-(5-chloropyridin-2-yl)-n(2)-{(1s,2r,4s)-4-(dimethylcarbamoyl)-2-[(5-methyl-4,5,6,7-tetrahydro[1,3]thiazolo[5,4-c]pyridine-2-carbonyl)amino]cyclohexyl}ethanediamide

47. N-(5-chloro-2-pyridinyl)-n'-[4-(dimethylcarbamoyl)-2-{[(5-methyl-4,5,6,7-tetrahydro[1,3]thiazolo[5,4-c]pyridin-2-yl)carbonyl]amino}cyclohexyl]ethanediamide;

48. N-(5-chloropyridin-2-yl)-n'-[(1s,2r,4s)-4-(dimethylcarbamoyl)-2-[(5-methyl-6,7-dihydro-4h-[1,3]thiazolo[5,4-c]pyridine-2-carbonyl)amino]cyclohexyl]oxamide

49. N-(5-chloropyridin-2-yl)-n'-[(1s,2r,4s)-4-(dimethylcarbamoyl)-2-{[(5-methyl-4,5,6,7-tetrahydro[1,3]thiazolo[5,4-c]pyridin-2-yl)carbonyl]amino}cyclohexyl]ethanediamide

50. N1-(5-chloropyridin-2-yl)-n2-((1s,2r,4s)-4-[(dimethylamino)carbonyl]-2-{[(5-methyl-4,5, 6,7-tetrahydrothiazolo[5,4-c]pyridin-2-yl)carbonyl]amino}cyclohexyl) Ethanediamide

51. N1-(5-chloropyridin-2-yl)-n2-((1s,2r,4s)-4-[(dimethylamino)carbonyl]-2-{[(5-methyl-4,5,6,7-tetrahydrothiazolo[5,4-c]pyridin-2-yl)carbonyl]amino}cyclohexyl)ethanediamide

52. N1-(5-chloropyridin-2-yl)-n2-[(1s,2r,4s)-4-(dimethylcarbamoyl)-2-{[(5-methyl-4,5,6,7-tetrahydro[1,3]thiazolo[5,4-c]pyridin-2-yl)carbonyl]amino}cyclohexyl]ethanediamide

2.3.3 Other Synonyms

1. Edoxaban (tosylate)

2. Edoxaban Tsoh Salt

2.4 Create Date

2006-10-25

3 Chemical and Physical Properties

Molecular Formula	C₂₄H₃₀ClN₇O₄S
Molecular Weight	548.1 g/mol
XLogP3	1.4
Hydrogen Bond Donor Count	3
Hydrogen Bond Acceptor Count	8
Rotatable Bond Count	5
Exact Mass	547.1768513 g/mol
Monoisotopic Mass	547.1768513 g/mol
Topological Polar Surface Area	165 Å²
Heavy Atom Count	37
Formal Charge	0
Complexity	880
Isotope Atom Count	0
Defined Atom Stereocenter Count	3
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 Therapeutic Uses

Factor Xa Inhibitors

National Library of Medicine's Medical Subject Headings. Edoxaban. Online file (MeSH, 2018). Available from, as of March 7, 2018: https://meshb.nlm.nih.gov/search

/CLINICAL TRIALS/ ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. The Web site is maintained by the National Library of Medicine (NLM) and the National Institutes of Health (NIH). Each ClinicalTrials.gov record presents summary information about a study protocol and includes the following: Disease or condition; Intervention (for example, the medical product, behavior, or procedure being studied); Title, description, and design of the study; Requirements for participation (eligibility criteria); Locations where the study is being conducted; Contact information for the study locations; and Links to relevant information on other health Web sites, such as NLM's MedlinePlus for patient health information and PubMed for citations and abstracts for scholarly articles in the field of medicine. Edoxaban is included in the database.

NIH/NLM; ClinicalTrials.Gov. Available from, as of March 7, 2018: https://clinicaltrials.gov/

Savaysa is indicated to reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF). /Included in US product label/

NIH; DailyMed. Current Medication Information for Savaysa (Edoxaban Tosylate) Tablet, Film-coated (Updated: November 6, 2017). Available from, as of March 22, 2018: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e77d3400-56ad-11e3-949a-0800200c9a66

Savaysa is indicated for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) following 5 to 10 days of initial therapy with a parenteral anticoagulant. /Included in US product label/

For more Therapeutic Uses (Complete) data for Edoxaban (7 total), please visit the HSDB record page.

4.2 Drug Warning

/BOXED WARNING/ REDUCED EFFICACY IN NONVALVULAR ATRIAL FIBRILLATION PATIENTS WITH CRCL > 95 ML/MIN. Savaysa should not be used in patients with CrCL > 95 mL/min. In the ENGAGE AF-TIMI 48 study, nonvalvular atrial fibrillation patients with CrCL > 95 mL/min had an increased rate of ischemic stroke with Savaysa 60 mg once daily compared to patients treated with warfarin. In these patients another anticoagulant should be used.

/BOXED WARNING/ PREMATURE DISCONTINUATION OF SAVAYSA INCREASES THE RISK OF ISCHEMIC EVENTS. Premature discontinuation of any oral anticoagulant in the absence of adequate alternative anticoagulation increases the risk of ischemic events. If Savaysa is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant as described in the transition guidance.

/BOXED WARNING/ SPINAL/EPIDURAL HEMATOMA. Epidural or spinal hematomas may occur in patients treated with Savaysa who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include: use of indwelling epidural catheters; concomitant use of other drugs that affect hemostasis, such as nonsteroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants; a history of traumatic or repeated epidural or spinal punctures; a history of spinal deformity or spinal surgery; optimal timing between the administration of Savaysa and neuraxial procedures is not known. Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessar. Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated.

Safety and efficacy of edoxaban have not been evaluated in patients with mechanical heart valves or moderate to severe mitral stenosis; use of the drug is not recommended in such patients.

American Society of Health-System Pharmacists 2017; Drug Information 2017. Bethesda, MD. 2017, p. 1639

For more Drug Warnings (Complete) data for Edoxaban (18 total), please visit the HSDB record page.

4.3 Drug Indication

Edoxaban is indicated for reducing the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF). However, it should not be used in patients with creatinine clearance (CrCL) > 95 mL/min because of increased risk of ischemic stroke compared to warfarin at the highest dose studied (60 mg). It is also indicated for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) following 5-10 days of initial therapy with a parenteral anticoagulant.

FDA Label

Prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age 75 years, diabetes mellitus, prior stroke or transient ischaemic attack (TIA).

Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.

5 Pharmacology and Biochemistry

5.1 Pharmacology

Administration of edoxaban results in prolongation of clotting time tests such as aPTT (activated partial thromboplastin time), PT (prothrombin time), and INR (international normalized ratio).

5.2 MeSH Pharmacological Classification

Factor Xa Inhibitors

Endogenous factors and drugs that inhibit or block the activity of FACTOR XA. (See all compounds classified as Factor Xa Inhibitors.)

5.3 FDA Pharmacological Classification

5.3.1 Active Moiety

EDOXABAN

5.3.2 FDA UNII

NDU3J18APO

5.3.3 Pharmacological Classes

Mechanisms of Action [MoA] - Factor Xa Inhibitors

5.4 ATC Code

B01

B01AF03

B - Blood and blood forming organs

B01 - Antithrombotic agents

B01A - Antithrombotic agents

B01AF - Direct factor xa inhibitors

B01AF03 - Edoxaban

5.5 Absorption, Distribution and Excretion

Absorption

Following oral administration, peak plasma edoxaban concentrations are observed within 1-2 hours. Absolute bioavailability is 62%.

Route of Elimination

Edoxaban is eliminated primarily as unchanged drug in urine. Renal clearance (11 L/hour) accounts for approximately 50% of the total clearance of edoxaban (22 L/hour). Metabolism and biliary/intestinal excretion account for the remaining clearance.

Volume of Distribution

The steady state volume of distribution is 107 L.

Clearance

22 L/hr

/MILK/ There are no data on the presence of edoxaban in human milk ... . Edoxaban was present in rat milk. ...

Disposition is biphasic. The steady-state volume of distribution (Vdss) is 107 (19.9) L (mean (SD)). In vitro plasma protein binding is approximately 55%. There is no clinically relevant accumulation of edoxaban (accumulation ratio 1.14) with once daily dosing.

Administration of a crushed 60 mg tablet, either mixed into applesauce or suspended in water and given through a nasogastric tube, showed similar exposure compared to administration of an intact tablet.

Edoxaban is eliminated primarily as unchanged drug in the urine. Renal clearance (11 L/hour) accounts for approximately 50% of the total clearance of edoxaban (22 L/hour). Metabolism and biliary/intestinal excretion account for the remaining clearance.

Following oral administration, peak plasma edoxaban concentrations are observed within 1-2 hours. Absolute bioavailability is 62%. Food does not affect total systemic exposure to edoxaban. Savaysa was administered with or without food in the ENGAGE AF-TIMI 48 and Hokusai VTE trials.

5.6 Metabolism/Metabolites

Edoxaban is not extensively metabolized by CYP3A4 resulting in minimal drug-drug interactions. However, it does interact with drugs that inhibit p-gp (p-glycoprotein), which is used to transport edoxaban across the intestinal wall. Unchanged edoxaban is the predominant form in plasma. There is minimal metabolism via hydrolysis (mediated by carboxylesterase 1), conjugation, and oxidation by CYP3A4. The predominant metabolite M-4, formed by hydrolysis, is human-specific and active and reaches less than 10% of the exposure of the parent compound in healthy subjects. Exposure to the other metabolites is less than 5% of exposure to edoxaban.

... All subjects received a single oral 60 mg edoxaban dose in period 1, and 7 days of 600 mg rifampin (2 x 300 mg capsules once daily) with a single oral edoxaban 60 mg dose administered concomitantly on day 7 in period 2. A 6-day washout period separated the treatments. Plasma concentrations of edoxaban and its metabolites M4 and M6 were measured, and limited assessments of pharmacodynamic markers of coagulation were performed. In total, 34 healthy subjects were enrolled; 32 completed the study. Coadministration of rifampin with edoxaban decreased edoxaban exposure but increased active metabolite exposure. Rifampin increased apparent oral clearance of edoxaban by 33% and decreased its half-life by 50%. Anticoagulant effects based on the prothrombin time (PT) and the activated partial thromboplastin time (aPTT) with and without rifampin at early time points were maintained to a greater-than-expected degree than with edoxaban exposure alone, presumably because of an increased contribution from the active metabolites. Edoxaban was well tolerated in this healthy adult population. Rifampin reduced exposure to edoxaban while increasing exposure to its active metabolites M4 and M6. PT and aPTT at early time points did not change appreciably; however, the data should be interpreted with caution.

PMID:26068927 Full text: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4488474 Mendell J et al; Clin Drug Investig 35 (7): 447-53 (2015)

Edoxaban and its low-abundance, active metabolite M4 are substrates of P-glycoprotein (P-gp; MDR1) and organic anion transporter protein 1B1 (OATP1B1), respectively, and pharmacological inhibitors of P-gp and OATP1B1 can affect edoxaban and M4 pharmacokinetics (PK). In this integrated pharmacogenomic analysis, genotype and concentration-time data from 458 healthy volunteers in 14 completed phase 1 studies were pooled to examine the impact on edoxaban PK parameters of allelic variants of ABCB1 (rs1045642: C3435T) and SLCO1B1 (rs4149056: T521C), which encode for P-gp and OATP1B1. Although some pharmacologic inhibitors of P-gp and OATP1B1 increase edoxaban exposure, neither the ABCB1 C3435T nor the SLCO1B1 T521C polymorphism affected edoxaban PK. A slight elevation in M4 exposure was observed among SLCO1B1 C-allele carriers; however, this elevation is unlikely to be clinically significant as plasma M4 concentrations comprise <10% of total edoxaban levels.

PMID:27897269 Full text: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5817390 Vandell AG et al; Pharmacogenomics J 18 (1): 153-159 (2018)

The predominant metabolite M-4, formed by hydrolysis, is human-specific and active and reaches less than 10% of the exposure of the parent compound in healthy subjects. Exposure to the other metabolites is less than 5% of exposure to edoxaban.

Unchanged edoxaban is the predominant form in plasma. There is minimal metabolism via hydrolysis (mediated by carboxylesterase 1), conjugation, and oxidation by CYP3A4.

5.7 Biological Half-Life

The terminal elimination half-life of edoxaban following oral administration is 10 to 14 hours.

5.8 Mechanism of Action

Edoxaban is a selective inhibitor of factor Xa, a serine endopeptidase of the clotting cascade required for cleavage of prothrombin into thrombin.

Edoxaban tosylate monohydrate, an oral, direct activated factor X (Xa) inhibitor, is an anticoagulant. Factor Xa plays a central role in the blood coagulation cascade by serving as the convergence point for the intrinsic and extrinsic pathways; inhibition of coagulation factor Xa by edoxaban prevents conversion of prothrombin to thrombin and subsequent thrombus formation. The drug binds directly and selectively to factor Xa without the need for a cofactor (e.g., antithrombin III), and inhibits both free and prothrombinase-bound factor Xa as well as thrombin-induced platelet aggregation.

American Society of Health-System Pharmacists 2017; Drug Information 2017. Bethesda, MD. 2017, p. 1640

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Edoxaban Tosylate Monohydrate

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Edoxaban Tosylate Monohydrate

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DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 38201

Submission : 2023-03-24

Status : Active

Type : II

03

Daiichi Sankyo Co Ltd

Japan

China

Antibody Engineering

Not Confirmed

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EU WC

01

TAPI Technology & API Services

Israel

CPhI WW Frankfurt

Booth #6.1A32

TAPI offers customized CDMO Solutions for API development and manufacturing services.

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Israel

Virtual Booth

Digital Content

Edoxaban Tosylate IH

Date of Issue : 2022-06-22

Valid Till : 2025-05-20

Written Confirmation Number : WC-0001

Address of the Firm : Q-1-4,Industrial area ,Ghinrongi Malanpur -477 117, Dist -Bhind (MP)

Corporate PDF

02

HONOUR LAB LTD

India

Antibody Engineering

Not Confirmed

03

MSN Laboratories

India

Antibody Engineering

Not Confirmed

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KDMF

01

Moehs Iberica

Spain

CPhI WW Frankfurt

Booth #11.0C6

Moehs Group, a reference company in the production of pharmaceutical active ingredients.

Contact Supplier

Spain

Virtual Booth

Digital Content

Edoxaban Tosilate

Registrant Name : Samoh Pharmaceutical Co., Ltd.

Registration Date : 2023-06-07

Registration Number : Su207-60-ND

Manufacturer Name : COPRIMA SL

Manufacturer Address : Pablo Picasso, 15 08213 Polinya (Barcelona), Spain

02

Hanseo Chem

South Korea

Pharma, Lab & Chemical Expo

Not Confirmed

03

HONOUR LAB LTD

Pharma, Lab & Chemical Expo

Not Confirmed

07

Pharmacostech

South Korea

Pharma, Lab & Chemical Expo

Not Confirmed

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NDC API

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API Reference Price

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&","customerCountry":"GERMANY","quantity":"109.40","actualQuantity":"109.4","unit":"KGS","unitRateFc":"2250","totalValueFC":"223896.8","currency":"USD","unitRateINR":172707.93994515538,"date":"02-Nov-2024","totalValueINR":"18894248.63","totalValueInUsd":"223896.8","indian_port":"Vizag-HIPL SEZ","hs_no":"29339990","bill_no":"5326427","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"Vizag-HIPL SEZ","supplierAddress":"8-3-166\/7\/1, HETERO HOUSE,, HYDERABAD, AP.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732645800,"product":"EDOXABAN TOSYLATE MONOHYDRATE","address":"8-3-166\/7\/1, HETERO HOUSE,","city":"HYDERABAD, AP.","supplier":"HONOUR LAB LTD","supplierCountry":"INDIA","foreign_port":"HAMBURG","customer":"ICARGO INTERNATIONALE LOGISTIK &","customerCountry":"GERMANY","quantity":"221.93","actualQuantity":"221.93","unit":"KGS","unitRateFc":"2250","totalValueFC":"456440.4","currency":"USD","unitRateINR":173560.02041184157,"date":"27-Nov-2024","totalValueINR":"38518175.33","totalValueInUsd":"456440.4","indian_port":"Vizag-HIPL SEZ","hs_no":"29339990","bill_no":"5943039","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"Vizag-HIPL SEZ","supplierAddress":"8-3-166\/7\/1, HETERO HOUSE,, HYDERABAD, AP.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732732200,"product":"EDOXABAN TOSYLATE MONOHYDRATE","address":"8-3-166\/7\/1, HETERO HOUSE,","city":"HYDERABAD, AP.","supplier":"HONOUR LAB LTD","supplierCountry":"INDIA","foreign_port":"HAMBURG","customer":"ICARGO INTERNATIONALE LOGISTIK &","customerCountry":"GERMANY","quantity":"221.93","actualQuantity":"221.93","unit":"KGS","unitRateFc":"2250","totalValueFC":"493541.3","currency":"USD","unitRateINR":187667.52178614878,"date":"28-Nov-2024","totalValueINR":"41649053.11","totalValueInUsd":"493541.3","indian_port":"Vizag-HIPL SEZ","hs_no":"29339990","bill_no":"5972982","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"Vizag-HIPL SEZ","supplierAddress":"8-3-166\/7\/1, HETERO HOUSE,, HYDERABAD, AP.","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1652985000,"product":"EDOXABAN TOSYLATE MONOHYDRATE API (BATCH NO.2) (1 PKG) (EDOXABAN TOSYLATE MONOHYDRATE) (FOR R&D PURPOSE ONLY)","address":"B\/2 MAHALAXMI CHAMBERS 22 BHULABHAI DESAI ROAD Contact No:","city":"MUMBAI","supplier":"COPRIMA S.L.","supplierCountry":"SPAIN","foreign_port":"NA","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.65","actualQuantity":"0.65","unit":"KGS","unitRateFc":"8000","totalValueFC":"5594.6","currency":"EUR","unitRateINR":"665200","date":"20-May-2022","totalValueINR":"432380","totalValueInUsd":"5594.6","indian_port":"BOMBAY AIR","hs_no":"29349990","bill_no":"8756282","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"B\/2 MAHALAXMI CHAMBERS 22 BHULABHAI DESAI ROAD Contact No:"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1653849000,"product":"EDOXABAN TOSYLATE MONOHYDRATE API (BATCH NO.1MCJ)(EDOXABAN)(FOR R&D PURPOSE ONLY)","address":"B\/2 MAHALAXMI CHAMBERS 22 BHULABHAI DESAI ROAD Contact No:","city":"MUMBAI","supplier":"COPRIMA S.L.","supplierCountry":"SPAIN","foreign_port":"NA","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"8000","totalValueFC":"8607","currency":"EUR","unitRateINR":"665200","date":"30-May-2022","totalValueINR":"665200","totalValueInUsd":"8607","indian_port":"BOMBAY AIR","hs_no":"29349990","bill_no":"8900827","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"B\/2 MAHALAXMI CHAMBERS 22 BHULABHAI DESAI ROAD Contact No:"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1663180200,"product":"EDOXABAN TOSYLATE MONOHYDRATE (BATCH NO. 1MCJ)","address":"B\/2 MAHALAXMI CHAMBERS 22 BHULABHAI DESAI ROAD Contact No:","city":"MUMBAI","supplier":"M\/S. COPRIMA S.L..","supplierCountry":"SPAIN","foreign_port":"NA","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"8000","totalValueFC":"8110.7","currency":"EUR","unitRateINR":"650000","date":"15-Sep-2022","totalValueINR":"650000","totalValueInUsd":"8110.7","indian_port":"BOMBAY AIR","hs_no":"29349990","bill_no":"2450837","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"B\/2 MAHALAXMI CHAMBERS 22 BHULABHAI DESAI ROAD Contact No:"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1664994600,"product":"EDOXABAN TOSYLATE","address":"PLOT NO 2A & 2B, BIOTECH PARK,,PHA SE II, LALGADI MALAKPET,","city":"HYDERABAD,TELANGANA","supplier":"ZHEJIANG SUPOR PHARMACEUTICALS CO., LTD","supplierCountry":"CHINA","foreign_port":"NA","customer":"CHEMO","customerCountry":"INDIA","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"3110","totalValueFC":"6077.6","currency":"USD","unitRateINR":"250044","date":"06-Oct-2022","totalValueINR":"500088","totalValueInUsd":"6077.6","indian_port":"HYDERABAD AIR","hs_no":"29349990","bill_no":"2751244","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"PLOT NO 2A & 2B, BIOTECH PARK,,PHA SE II, LALGADI MALAKPET,"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1671733800,"product":"EDOXABAN TOSYLATE MONOHYDRATE","address":"SURVEY NO.42, GADDAPOTHARAM,KAZIPA LLY IND AREA, SANGAREDDY DIST","city":"GADDAPOTHARAM HYD,TELANGANA","supplier":"COPRIMA S.L","supplierCountry":"SPAIN","foreign_port":"NA","customer":"TIEFENBACHER API + INGREDIENTS GMBH","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"9200","totalValueFC":"10014.3","currency":"EUR","unitRateINR":"825240","date":"23-Dec-2022","totalValueINR":"825240","totalValueInUsd":"10014.3","indian_port":"HYDERABAD AIR","hs_no":"29349990","bill_no":"3871918","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"SURVEY NO.42, GADDAPOTHARAM,KAZIPA LLY IND AREA, SANGAREDDY DIST"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1675449000,"product":"TERT-BUTYL((1R,2S,5S)-2-AMINO-5-(DIMETHYLCARBAMOYL)CYCLOHEXYL)CARBAMATE OXALATE HYDRATE (LAB CHEMICAL)(EDOXABAN A OXALAT","address":"717\/718, MAKER CHAMBER V,,NARIMAN POINT,","city":"MUMBAI,MAHARASHTRA","supplier":"ZHEJIANG EAZY PHARMCHEM CO LTD.","supplierCountry":"CHINA","foreign_port":"NA","customer":"HIKAL","customerCountry":"INDIA","quantity":"3.00","actualQuantity":"3","unit":"KGS","unitRateFc":"1400","totalValueFC":"4208.1","currency":"USD","unitRateINR":"115850","date":"04-Feb-2023","totalValueINR":"347550","totalValueInUsd":"4208.1","indian_port":"BOMBAY AIR","hs_no":"29242990","bill_no":"4487208","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"717\/718, MAKER CHAMBER V,,NARIMAN POINT,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1678645800,"product":"(FOC) COMMON BLEND OF EDOXABAN TABLETS 15MG, 30MG AND 60MG","address":"12TH FLOOR, COMMERZ II,,INTERNATIO NAL BUSNESS PARK,OBEROI","city":"GARDEN CITY OFF WESTERN EXPR HIGHWA","supplier":"ACTAVIS INC","supplierCountry":"MALTA","foreign_port":"NA","customer":"TEVA PHARMACEUTICAL INDUSTRIES","customerCountry":"INDIA","quantity":"4.87","actualQuantity":"4.87","unit":"KGS","unitRateFc":"1031","totalValueFC":"5473.6","currency":"EUR","unitRateINR":"92445","date":"13-Mar-2023","totalValueINR":"450206.96","totalValueInUsd":"5473.6","indian_port":"BOMBAY AIR","hs_no":"29349990","bill_no":"5030651","productDescription":"API","marketType":"REGULATED MARKET","country":"MALTA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"12TH FLOOR, COMMERZ II,,INTERNATIO NAL BUSNESS PARK,OBEROI"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1689705000,"product":"EDOXABAN TOSYLATE MONOHYDRATE API (BATCH NO.5MCJ, 6MCJ) (EDOXABAN TOSYLATE MONOHYDRATE)","address":"B\/2 MAHALAXMI CHAMBERS 22 BHULABHAI DESAI ROAD Contact No:","city":"MUMBAI","supplier":"COPRIMA S.L.","supplierCountry":"SPAIN","foreign_port":"NA","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"55.00","actualQuantity":"55","unit":"KGS","unitRateFc":"3260","totalValueFC":"181613.5","currency":"USD","unitRateINR":"271394.7","date":"19-Jul-2023","totalValueINR":"14926725.25","totalValueInUsd":"181613.5","indian_port":"BOMBAY AIR","hs_no":"29349990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"B\/2 MAHALAXMI CHAMBERS 22 BHULABHAI DESAI ROAD Contact No:"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1724610600,"product":"EDOXABAN TOSYLATE MONOHYDRATE(API)(IUPAC NAME N-5-CHLOROPYRIDIN-2-YL)-N-(1S,2R,4S)-4-(DIMETHYLCARBAMOYL)2-5,METHYL-6,7-D","address":"CISONS COMPLEX,SHOPNO.77, 1ST FLOOR","city":"ROAD, EGMORE, CHENNAI, TAMIL NADU","supplier":"HANGZHOU CELOR CHEMICAL","supplierCountry":"CHINA","foreign_port":"HANGCHOW (HANGZHOU)","customer":"SYMBIO GENERRICS INDIA ","customerCountry":"INDIA","quantity":"0.10","actualQuantity":"0.1","unit":"KGS","unitRateFc":"2500","totalValueFC":"252.9","currency":"USD","unitRateINR":"212125","date":"26-Aug-2024","totalValueINR":"21212.5","totalValueInUsd":"252.9","indian_port":"Bangalore Air","hs_no":"29339990","bill_no":"5259361","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HANGCHOW (HANGZHOU)","supplierAddress":"BLOCK E-1804 WANTONG CENTER,189DAGUAN ROAD-ANGZHOU 310015SDNF CHINA","customerAddress":"CISONS COMPLEX,SHOPNO.77, 1ST FLOOR"}]

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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Drugs in Development

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INTERMEDIATES SUPPLIERS

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FDF Dossiers

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FDA Orange Book

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Europe

01

Daiichi Sankyo (Switzerland) AG

Japan

Pharma, Lab & Chemical Expo

Not Confirmed

02

Daiichi Sankyo (Switzerland) AG

Japan

Pharma, Lab & Chemical Expo

Not Confirmed

03

Daiichi Sankyo (Switzerland) AG

Japan

Pharma, Lab & Chemical Expo

Not Confirmed

04

DAIICHI SANKYO EUROPE GmbH

Country

Pharma, Lab & Chemical Expo

Not Confirmed

Not Confirmed

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Listed Dossiers

01

Dr. Reddy's Laboratories

India

Antibody Engineering

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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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India

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Registration Country : India

Edoxaban Tosylate

Brand Name :

Dosage Form : Oral Solid Dosage Form

Dosage Strength : 15MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Lead Market Dossiers- Under De...

Registration Country : India

02

Dr. Reddy's Laboratories

India

Antibody Engineering

Not Confirmed

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Contact Supplier

India

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Registration Country : India

Edoxaban Tosylate

Brand Name :

Dosage Form : Oral Solid Dosage Form

Dosage Strength : 30MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Lead Market Dossiers- Under De...

Registration Country : India

03

Dr. Reddy's Laboratories

India

Antibody Engineering

Not Confirmed

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Contact Supplier

India

Virtual Booth

Digital Content

Regulatory Info : Lead Market Dossiers- Under De...

Registration Country : India

Edoxaban Tosylate

Brand Name :

Dosage Form : Oral Solid Dosage Form

Dosage Strength : 60MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Lead Market Dossiers- Under De...

Registration Country : India

04

Titan Laboratories Pvt Ltd.

India

Antibody Engineering

Not Confirmed

05

Titan Laboratories Pvt Ltd.

India

Antibody Engineering

Not Confirmed

06

Titan Laboratories Pvt Ltd.

India

Antibody Engineering

Not Confirmed

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Digital Content

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US Medicaid Prescriptions

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Finished Drug Prices

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Market Place

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APIs

Edoxaban Tosylate API needed in Oman [ENA19821]

A company that focuses on manufacturing and development of various finished formulation including oral solid, oral liquid & topical dosage forms is looking for suppliers of USP/ Ph. Eur. Grade Edoxaban Tosylate API for both development & commercial purposes. The required quantity 3.5 kg for first year, 17.1 kg for second year, 32.1 kg for third year, 39.3 kg for fourth year, 47.4 kg for fifth year & 56 kg for sixth year. The suppliers must support this enquiry with USDMF/ CEP/WC, GMP & CoA.

27 Jun 2024

Edoxaban API needed in India [ENA18797]

A CDMO that focuses on the research, development & manufacturing of tablets, capsules, creams, gels and sprays is looking for suppliers of Edoxaban API (2 kg - 5 kg) API for development purposes. The suppliers must support this enquiry with CoA.

21 Dec 2023

Various APIs needed in South Korea [ENA14553]

A company that focuses in development, manufacturing & marketing a wide range of finished formulations is looking for suppliers of Various APIs for commercial purpose. The suppliers must support this enquiry with KDMF. 1. Apixaban API 2. Edoxaban API

02 Aug 2022

Various APIs needed in India [ENA14327]

A company that focuses in the research & development of active pharmaceutical ingredients, intermediates and related substances is looking for suppliers of Various APIs for development purpose. 1. Edoxaban (5 g or 10 g) API 2. Lumateperone (10 g) API 3. Tenofovir Alafenamide Fumarate (5 g or 10 g) API 4. Emtricitabine (5 g or 10 g) API

14 Jul 2022

Various APIs needed in India [ENA14139]

A CRO that focuses in formulation & analytical development is looking for suppliers of Various APIs for development purpose. The suppliers must support this enquiry with EDMF/ CEP & CoA. The final market is Europe. 1. BP/ EP Grade Lumateperone Tosylate (5 kg - 10 kg) API 2. BP/ EP Grade Edoxaban (5 kg - 10 kg) API 3. BP/ EP Grade Emtricitabine (20 kg) API 4. BP/ EP Grade Tenofovir Alafenamide Fumarate (20 kg) API

29 Jun 2022

Edoxaban (50 g - 100 g) API needed in Japan [ENA11949]

A company that deals in the research & development of various pharmaceutical products is looking for suppliers of Edoxaban (50 g - 100 g) API for development purpose.

27 Nov 2021

Various APIs needed in Korea [ENA09880]

Rihu Healthcare, a leading value-added and multifunctional trader and distributor of pharmaceutical products, chemicals and functional health industries is looking for suppliers of Various APIs. The suppliers must support this enquiry with WHO GMP, COA and CTD for KDMF registration. Interested suppliers can contat them via their email: justin.lim@rihuhealthcare.com. 1. Valsartan Sodium API 2. Edoxaban Base API 3. Edoxaban Tosylate API

05 Mar 2021

Edoxaban Tosylate API needed in India [ENAO5704]

Zas Pharma, a trading and distributor company in India is looking for suppliers of Edoxaban Tosylate API. The Supplier must support this enquiry with CoA. Interested suppliers can contact them via Email: zaspharma2827@gmail.com.

09 Nov 2019

Edoxaban Tosylate (MOQ) API needed in Egypt [ENA05671]

Namaa for Trading & Agencies, one of the largest distributors of chemical products in the Middle East and African markets is looking for suppliers of Edoxaban Tosylate API (1 kg/6 kg). The supplier must support this enquiry with CoA & GMP certificate. Interested suppliers can contact them via E-mail: namaa@namaatrading.com or Mob : +2 01129861403.

05 Nov 2019

Edoxaban (50 kg) API needed in China [ENA05096]

A pharmaceutical company developed into a provincial high-tech enterprise that engages in research, development, manufacturing, and trade of high end pharmaceutical intermediates and APIs is looking for suppliers of Edoxaban (50 kg) API. The supplier must support this enquiry with GMP.

07 Sep 2019

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EDOXABAN TOSYLATE

Antibody Engineering

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US Exclusivities

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REF. STANDARDS & IMPURITIES

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

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DEVELOPMENTS

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ACTIVE PHARMA INGREDIENTS

API REF. PRICE (USD/KG)

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