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Chemistry

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Also known as: 503612-47-3, Eliquis, Bms-562247, Bms-562247-01, Bms 562247-01, 1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5,6,7-tetrahydro-1h-pyrazolo[3,4-c]pyridine-3-carboxamide
Molecular Formula
C25H25N5O4
Molecular Weight
459.5  g/mol
InChI Key
QNZCBYKSOIHPEH-UHFFFAOYSA-N
FDA UNII
3Z9Y7UWC1J

Apixaban
Apixaban is an orally active inhibitor of coagulation factor Xa with anticoagulant activity. Apixaban directly inhibits factor Xa, thereby interfering with the conversion of prothrombin to thrombin and preventing formation of cross-linked fibrin clots.
Apixaban is a Factor Xa Inhibitor. The mechanism of action of apixaban is as a Factor Xa Inhibitor.
1 2D Structure

Apixaban

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5-dihydropyrazolo[3,4-c]pyridine-3-carboxamide
2.1.2 InChI
InChI=1S/C25H25N5O4/c1-34-19-11-9-18(10-12-19)30-23-20(22(27-30)24(26)32)13-15-29(25(23)33)17-7-5-16(6-8-17)28-14-3-2-4-21(28)31/h5-12H,2-4,13-15H2,1H3,(H2,26,32)
2.1.3 InChI Key
QNZCBYKSOIHPEH-UHFFFAOYSA-N
2.1.4 Canonical SMILES
COC1=CC=C(C=C1)N2C3=C(CCN(C3=O)C4=CC=C(C=C4)N5CCCCC5=O)C(=N2)C(=O)N
2.2 Other Identifiers
2.2.1 UNII
3Z9Y7UWC1J
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Bms 562247

2. Bms-562247

3. Bms-562247-01

4. Bms562247

5. Eliquis

2.3.2 Depositor-Supplied Synonyms

1. 503612-47-3

2. Eliquis

3. Bms-562247

4. Bms-562247-01

5. Bms 562247-01

6. 1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5,6,7-tetrahydro-1h-pyrazolo[3,4-c]pyridine-3-carboxamide

7. 1-(4-methoxyphenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-4,5,6,7-tetrahydro-1h-pyrazolo[3,4-c]pyridine-3-carboxamide

8. 1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5-dihydropyrazolo[3,4-c]pyridine-3-carboxamide

9. 3z9y7uwc1j

10. Chembl231779

11. Chebi:72296

12. Bms562247-01

13. Apixaban-13c,d3

14. 1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-1h,4h,5h,6h,7h-pyrazolo[3,4-c]pyridine-3-carboxamide

15. 1-(4-methoxy-phenyl)-7-oxo-6-[4-(2-oxo-piperidin-1-yl)-phenyl]-4,5,6,7-tetrahydro-1h-pyrazolo[3,4-c]pyridine-3-carboxylic Acid Amide

16. 1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5-dihydropyrazolo[5,4-c]pyridine-3-carboxamide

17. Apixaban [usan]

18. Gg2

19. Eliquis (tn)

20. Unii-3z9y7uwc1j

21. Apixabanum

22. Apixaban (jan/usan/inn)

23. Apixaban [usan:inn:jan]

24. Hsdb 8223

25. Apixaban- Bio-x

26. Apixaban(bms-562247-01)

27. Apixaban-[d3]

28. Bms 562247

29. Apixaban [inn]

30. Apixaban [jan]

31. Apixaban [mi]

32. Apixaban [vandf]

33. Apixaban [mart.]

34. Apixaban [who-dd]

35. Apixaban - Adooq Bioscience

36. Apixaban [ema Epar]

37. Mls006010026

38. Schembl118023

39. Apixaban [orange Book]

40. Gtpl6390

41. Apixaban,bms-562247-01

42. Bdbm19023

43. Amy1826

44. Dtxsid80436500

45. Ex-a048

46. 2p16

47. Bcpp000396

48. Hms3655o07

49. Bcp02451

50. 503612-47-3, Eliquis,

51. Apixaban (bms 562247-01)

52. Bms562247

53. Mfcd11977295

54. Nsc784102

55. S1593

56. Zinc11677837

57. Akos005146204

58. Bcp9000310

59. Ccg-229675

60. Cs-0401

61. Db06605

62. Me-0152

63. Nsc-784102

64. Pb10976

65. Ncgc00346555-01

66. Ncgc00346555-02

67. Ncgc00346555-05

68. Ncgc00346555-08

69. Ac-26301

70. Bm164185

71. Hy-50667

72. Smr004676529

73. Ft-0686944

74. Sw220177-1

75. D03213

76. Ab01565766_02

77. 612a473

78. Ar-270/43507990

79. Q414462

80. J-200194

81. 1-(4-methoxyphenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyi)-4,5,6,7-tetrahydro-1h-pyrazolo(3,4-c)pyridine-3-carboxamide

82. 1-(4-methoxyphenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-4,5,6,7-tetrahydro-1h-pyrazolo(3,4c)pyridine-3-carboxamide

83. 1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxo Piperidin-1-yl)phenyl]-4,5,6,7-tetrahydro-1h-pyrazolo[3,4-c]pyridine-3-carboxamide

84. 1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxo-1-piperidinyl)phenyl]-4,5,6,7-tetrahydro-1h-pyrazolo[3,4-c]pyridine-3-carboxamide

85. 1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5,6,7-tetrahydro-1h-pyrazolo[3,4-c]pyridine-3-carboxamide?bms-562247; Bms-562247-01

86. 1h-pyrazolo(3,4-c)pyridine-3-carboxamide, 4,5,6,7-tetrahydro-1-( 4-methoxyphenyl)-7-oxo-6-(4-(2-oxo-1-piperidinyl)phenyl)-

87. 1h-pyrazolo(3,4-c)pyridine-3-carboxamide,4,5,6,7-tetrahydro-1-(4-methoxyphenyl)-7-oxo-6-(4-(2-oxo-1-piperidinyl)phenyl)-

2.4 Create Date
2006-10-25
3 Chemical and Physical Properties
Molecular Weight 459.5 g/mol
Molecular Formula C25H25N5O4
XLogP32.2
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count5
Rotatable Bond Count5
Exact Mass459.19065430 g/mol
Monoisotopic Mass459.19065430 g/mol
Topological Polar Surface Area111 Ų
Heavy Atom Count34
Formal Charge0
Complexity777
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameEliquis
PubMed HealthApixaban (By mouth)
Drug ClassesAnticoagulant
Drug LabelELIQUIS (apixaban), a factor Xa (FXa) inhibitor, is chemically described as 1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide. Its molecular formula is C25H25N5O4, which correspond...
Active IngredientApixaban
Dosage FormTablet
RouteOral
Strength2.5mg; 5mg
Market StatusPrescription
CompanyBristol Myers Squibb

2 of 2  
Drug NameEliquis
PubMed HealthApixaban (By mouth)
Drug ClassesAnticoagulant
Drug LabelELIQUIS (apixaban), a factor Xa (FXa) inhibitor, is chemically described as 1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide. Its molecular formula is C25H25N5O4, which correspond...
Active IngredientApixaban
Dosage FormTablet
RouteOral
Strength2.5mg; 5mg
Market StatusPrescription
CompanyBristol Myers Squibb

4.2 Therapeutic Uses

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

NIH; DailyMed. Current Medication Information for Eliquis (Apixaban) Tablet, Film Coated (Revised: August 2014). Available from, as of March 26, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e9481622-7cc6-418a-acb6-c5450daae9b0


Eliquis is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery. /Included in US product label/

NIH; DailyMed. Current Medication Information for Eliquis (Apixaban) Tablet, Film Coated (Revised: August 2014). Available from, as of March 26, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e9481622-7cc6-418a-acb6-c5450daae9b0


Eliquis is indicated for the treatment of pulmonary embolism (PE). /Included in US product label/

NIH; DailyMed. Current Medication Information for Eliquis (Apixaban) Tablet, Film Coated (Revised: August 2014). Available from, as of March 26, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e9481622-7cc6-418a-acb6-c5450daae9b0


Eliquis is indicated for the treatment of deep vein thrombosis (DVT). /Included in US product label/

NIH; DailyMed. Current Medication Information for Eliquis (Apixaban) Tablet, Film Coated (Revised: August 2014). Available from, as of March 26, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e9481622-7cc6-418a-acb6-c5450daae9b0


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


4.3 Drug Warning

/BOXED WARNING/ WARNING: PREMATURE DISCONTINUATION OF ELIQUIS INCREASES THE RISK OF THROMBOTIC EVENTS. Premature discontinuation of any oral anticoagulant, including Eliquis, increases the risk of thrombotic events. If anticoagulation with Eliquis is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant.

NIH; DailyMed. Current Medication Information for Eliquis (Apixaban) Tablet, Film Coated (Revised: August 2014). Available from, as of March 26, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e9481622-7cc6-418a-acb6-c5450daae9b0


/BOXED WARNING/ WARNING: SPINAL/EPIDURAL HEMATOMA. Epidural or spinal hematomas may occur in patients treated with Eliquis 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 Eliquis and neuraxial procedures is not known. Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary. Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated.

NIH; DailyMed. Current Medication Information for Eliquis (Apixaban) Tablet, Film Coated (Revised: August 2014). Available from, as of March 26, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e9481622-7cc6-418a-acb6-c5450daae9b0


FDA Pregnancy Risk Category: B /NO EVIDENCE OF RISK IN HUMANS. Adequate, well controlled studies in pregnant women have not shown increased risk of fetal abnormalities despite adverse findings in animals, or, in the absence of adequate human studies, animal studies show no fetal risk. The chance of fetal harm is remote but remains a possibility./

NIH; DailyMed. Current Medication Information for Eliquis (Apixaban) Tablet, Film Coated (Revised: August 2014). Available from, as of March 26, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e9481622-7cc6-418a-acb6-c5450daae9b0


It is unknown whether apixaban or its metabolites are excreted in human milk. Rats excrete apixaban in milk (12% of the maternal dose). Women should be instructed either to discontinue breastfeeding or to discontinue Eliquis therapy, taking into account the importance of the drug to the mother.

NIH; DailyMed. Current Medication Information for Eliquis (Apixaban) Tablet, Film Coated (Revised: August 2014). Available from, as of March 26, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e9481622-7cc6-418a-acb6-c5450daae9b0


For more Drug Warnings (Complete) data for Apixaban (17 total), please visit the HSDB record page.


4.4 Drug Indication

Apixaban is indicated for reducing the risk of stroke and systemic embolism in patients who have nonvalvular atrial fibrillation, prophylaxis of deep vein thrombosis(DVT) leading to pulmonary embolism(PE) in patients after a hip or knee replacement surgery, and treatment of DVT and PE to reduce the risk of recurrence.


FDA Label


For

* Eliquis 2. 5 mg film-coated tablets: :

- Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery.

- Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class II).

- Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (see section 4. 4 for haemodynamically unstable PE patients).

For

* Eliquis 5 mg film-coated tablets: :

- Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class II).

- Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (see section 4. 4 for haemodynamically unstable PE patients).


Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery.

Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class II).

Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (see section 4. 4 for haemodynamically unstable PE patients).

Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class II).

Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (see section 4. 4 for haemodynamically unstable PE patients).


Treatment of venous thromboembolism


Prevention of arterial thromboembolism, Prevention of venous thromboembolism


5 Pharmacology and Biochemistry
5.1 Pharmacology

Apixaban selectively inhibits factor Xa in its free and bound forms, independant of antithrombin III. Apixaban also inhibits prothrominase. These effects prevent the formation of a thrombus.


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
APIXABAN
5.3.2 FDA UNII
3Z9Y7UWC1J
5.3.3 Pharmacological Classes
Factor Xa Inhibitors [MoA]; Factor Xa Inhibitor [EPC]
5.4 ATC Code

B01AF02


B01AF02


B01AF02

S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355


B - Blood and blood forming organs

B01 - Antithrombotic agents

B01A - Antithrombotic agents

B01AF - Direct factor xa inhibitors

B01AF02 - Apixaban


5.5 Absorption, Distribution and Excretion

Absorption

Apixaban is approximately 50% bioavailable though other studies report 43-46% oral bioavailability.


Route of Elimination

56% of an orally administered dose is recovered in the feces and 24.5-28.8% of the dose is recovered in the urine. 83-88% of the dose recovered in the urine was the unchanged parent compound.


Volume of Distribution

Approximately 21L.


Clearance

3.3L/h though other studies report 4876mL/h.


Distribution in pregnant rats/fetuses: Cmax in amnion was high. Significant concentrations were found in placenta and fetal blood, kidney and liver. Toxicokinetic data collected in the reproductive and developmental toxicity studies in rats, mice and rabbits showed that generally fetal plasma concentrations of apixaban were lower than those in the dams.

European Medicines Agency (EMA), Committee for Medicinal Products for Human Use (CHMP), European Public Assessment Report (EPAR): Eliquis (Apixaban) p.13 (2011). Available from, as of March 26, 2015: https://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002148/WC500107726.pdf


Two single dose radiolabel distribution studies were provided in rats. The data show a wide distribution, with the highest values in excretory organs (liver, kidney, urinary bladder (and contents), bile) and intestinal tract (and contents). After a dose of 20 mg/kg in male Long-Evans rats also relatively high Cmax and AUC were found in adrenals, lungs, thyroid gland, but after a dose of 5 mg/kg in Sprague Dawley rats (both sexes) these organs showed Cmax similar to most other organs and tissues. There was no qualitative difference in distribution between male and female rats, but the female rats showed higher Cmax values in the intestinal tract.

European Medicines Agency (EMA), Committee for Medicinal Products for Human Use (CHMP), European Public Assessment Report (EPAR): Eliquis (Apixaban) p.13 (2011). Available from, as of March 26, 2015: https://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002148/WC500107726.pdf


Protein binding differs between the species. The unbound fraction at concentrations of 1-10 uM is about 13% in human vs about 4% in rats and 8% in dogs. At the tested concentrations there was no effect of concentration or gender. In mice protein binding is much lower, with 44-6 % unbound, dependent on the tested concentration (range 100-2000 ng apixaban/mL).

European Medicines Agency (EMA), Committee for Medicinal Products for Human Use (CHMP), European Public Assessment Report (EPAR): Eliquis (Apixaban) p.13 (2011). Available from, as of March 26, 2015: https://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002148/WC500107726.pdf


Plasma to blood ratios of about one in dog and human blood indicate uniform distribution between plasma and red blood cells and thus no specific distribution to red blood cells.

European Medicines Agency (EMA), Committee for Medicinal Products for Human Use (CHMP), European Public Assessment Report (EPAR): Eliquis (Apixaban) p.13 (2011). Available from, as of March 26, 2015: https://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002148/WC500107726.pdf


For more Absorption, Distribution and Excretion (Complete) data for Apixaban (12 total), please visit the HSDB record page.


5.6 Metabolism/Metabolites

50% of the orally administered dose is excreted as the unchanged parent compound, however 25% of the dose is excreted as O-demethyl apixaban sulfate. All apixaban metabolites account for approximately 32% of the excreted dose though the structure of all metabolites are not well defined. Apixaban is mainly metabolized by cytochrome p450(CYP)3A4 and to a lesser extent by CYP1A2, CYP2C8, CYP2C9, CYP2C19, and CYP2J2.


Approximately 25% of an orally administered apixaban dose is recovered in urine and feces as metabolites. Apixaban is metabolized mainly via CYP3A4 with minor contributions from CYP1A2, 2C8, 2C9, 2C19, and 2J2. O-demethylation and hydroxylation at the 3-oxopiperidinyl moiety are the major sites of biotransformation. Unchanged apixaban is the major drug-related component in human plasma; there are no active circulating metabolites.

NIH; DailyMed. Current Medication Information for Eliquis (Apixaban) Tablet, Film Coated (Revised: August 2014). Available from, as of December 31, 2014: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e9481622-7cc6-418a-acb6-c5450daae9b0


Apixaban is mainly metabolized by CYP3A4/5 with conjugation via SULT1A1, but several other CYP and SULT isozymes are also involved. No apixaban metabolites were found to have pharmacological activity and there were no unique human metabolites.

European Medicines Agency (EMA), Committee for Medicinal Products for Human Use (CHMP), European Public Assessment Report (EPAR): Eliquis (Apixaban) p.13 (2011). Available from, as of March 26, 2015: https://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002148/WC500107726.pdf


The metabolism and disposition of (14)C-apixaban, an orally bioavailable, highly selective, and direct acting/reversible factor Xa inhibitor, was investigated in 10 healthy male subjects without (group 1, n=6) and with bile collection (group 2, n=4) after a single 20-mg oral dose. Urine, blood, and feces samples were collected from all subjects. Bile samples were also collected for 3 to 8 hr after dosing from group 2 subjects. There were no serious adverse events or discontinuations due to adverse effects. In plasma, apixaban was the major circulating component and O-demethyl apixaban sulfate, a stable and water-soluble metabolite, was the significant metabolite. The exposure of apixaban (C(max) and area under the plasma concentration versus time curve) in subjects with bile collection was generally similar to that in subjects without bile collection. The administered dose was recovered in feces (group 1, 56.0%; group 2, 46.7%) and urine (group 1, 24.5%; group 2, 28.8%), with the parent drug representing approximately half of the recovered dose. Biliary excretion represented a minor elimination pathway (2.44% of the administered dose) from group 2 subjects within the limited collection period. Metabolic pathways identified for apixaban included O-demethylation, hydroxylation, and sulfation of hydroxylated O-demethyl apixaban. Thus, apixaban is an orally bioavailable inhibitor of factor Xa with elimination pathways that include metabolism and renal excretion.

PMID:18832478 Raghavan N et al; Drug Metab Dispos 37 (1): 74-81 (2009)


The metabolism and disposition of (14)C-apixaban, a potent, reversible, and direct inhibitor of coagulation factor Xa, were investigated in mice, rats, rabbits, dogs, and humans after a single oral administration and in incubations with hepatocytes. In plasma, the parent compound was the major circulating component in mice, rats, dogs, and humans. O-Demethyl apixaban sulfate (M1) represented approximately 25% of the parent area under the time curve in human plasma. This sulfate metabolite was present, but in lower amounts relative to the parent, in plasma from mice, rats, and dogs. Rabbits showed a plasma metabolite profile distinct from that of other species with apixaban as a minor component and M2 (O-demethyl apixaban) and M14 (O-demethyl apixaban glucuronide) as prominent components. The fecal route was a major elimination pathway, accounting for >54% of the dose in animals and >46% in humans. The urinary route accounted for <15% of the dose in animals and 25 to 28% in humans. Apixaban was the major component in feces of every species and in urine of all species except rabbit. M1 and M2 were common prominent metabolites in urine and feces of all species as well as in bile of rats and humans. In vivo metabolite profiles showed quantitative differences between species and from in vitro metabolite profiles, but all human metabolites were found in animal species. After intravenous administration of (14)C-apixaban to bile duct-cannulated rats, the significant portion (approximately 22%) of the dose was recovered as parent drug in the feces, suggesting direct excretion of the drug from gastrointestinal tracts of rats. Overall, apixaban was effectively eliminated via multiple elimination pathways in animals and humans, including oxidative metabolism, and direct renal and intestinal excretion.

PMID:19420130 Zhang D et al; Drug Metab Dispos 37 (8): 1738-48 (2009)


... The O-demethyl apixaban sulfate is a major circulating metabolite in humans but circulates at lower concentrations relative to parent in animals. The aim of this study was to identify the sulfotransferases (SULTs) responsible for the sulfation reaction. Apixaban undergoes O-demethylation catalyzed by cytochrome P450 enzymes to O-demethyl apixaban, and then is conjugated by SULTs to form O-demethyl apixaban sulfate. Of the five human cDNA-expressed SULTs tested, SULT1A1 and SULT1A2 exhibited significant levels of catalytic activity for formation of O-demethyl apixaban sulfate, and SULT1A3, SULT1E1, and SULT2A1 showed much lower catalytic activities. In human liver S9, quercetin, a highly selective inhibitor of SULT1A1 and SULT1E1, inhibited O-demethyl apixaban sulfate formation by 99%; 2,6-dichloro-4-nitrophenol, another inhibitor of SULT1A1, also inhibited this reaction by >90%; estrone, a competitive inhibitor for SULT1E1, had no effect on this reaction. The comparable K(m) values for formation of O-demethyl apixaban sulfate were 41.4 microM (human liver S9), 36.8 microM (SULT1A1), and 70.8 microM (SULT1A2). Because of the high level of expression of SULT1A1 in liver and its higher level of catalytic activity for formation of O-demethyl apixaban sulfate, SULT1A1 might play a major role in humans for formation of O-demethyl apixaban sulfate. O-Demethyl apixaban was also investigated in liver S9 of mice, rats, rabbits, dogs, monkeys, and humans. The results indicated that liver S9 samples from dogs, monkeys, and humans had higher activities for formation of O-demethyl apixaban sulfate than those of mice, rats, and rabbits.

PMID:19131519 Wang L et al; Drug Metab Dispos 37 (4): 802-8 (2009)


5.7 Biological Half-Life

12.78.55h.


Apixaban has ... an apparent half-life of approximately 12 hours following oral administration.

NIH; DailyMed. Current Medication Information for Eliquis (Apixaban) Tablet, Film Coated (Revised: August 2014). Available from, as of March 26, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e9481622-7cc6-418a-acb6-c5450daae9b0


In a comparative study elimination half-life in rats (2-3 hrs) was shorter than in dogs (5-6 hrs) and chimpanzees (5-7 hrs). Distribution volume is relatively low in rats (0.31 L/kg), dogs (0.30 L/kg) and chimpanzees (0.17 L/kg).

European Medicines Agency (EMA), Committee for Medicinal Products for Human Use (CHMP), European Public Assessment Report (EPAR): Eliquis (Apixaban) p.13 (2011). Available from, as of March 26, 2015: https://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002148/WC500107726.pdf


... After a single oral administration ... the elimination half life of radioactivity in blood was 1.7 to 4.2 hr.

PMID:2107152 Wang L et al; Drug Metab Dispos 39 (2): 256-64 (2011)


5.8 Mechanism of Action

Apixaban selectively inhibits factor Xa in its free and bound forms, independant of antithrombin III. Apixaban also inhibits prothrominase. These effects prevent the formation of a thrombus.


API SUPPLIERS

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Polpharma

Poland

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Dr. Reddy's Laboratories

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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

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03

Minakem

France

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Virtual BoothMinakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.

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DKSH

Switzerland

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Virtual BoothDKSH is your trusted partner for companies looking to grow their business in Asia & beyond.

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05

Minakem (formerly Delmar Chemicals...

Canada

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Virtual BoothMinakem is manufacturing small molecules APIs including corticosteroids

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LGM Pharma

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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LGM Pharma CB

07

Metrochem API Private Limited

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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08

Rochem International Inc

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Virtual BoothRochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.

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Rochem

09

IOL Chemicals and Pharmaceuticals

India

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Virtual BoothIOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.

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IOL Chemicals

10

Jai Radhe Sales

India

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USDMF

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Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

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GDUFA

DMF Review : Complete

Rev. Date : 2017-02-10

Pay. Date : 2016-12-20

DMF Number : 31166

Submission : 2016-11-16

Status : Active

Type : II

Polpharma CB

02

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

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GDUFA

DMF Review : Complete

Rev. Date : 2016-03-11

Pay. Date : 2015-09-30

DMF Number : 29707

Submission : 2015-09-22

Status : Active

Type : II

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Virtual BoothMinakem is manufacturing small molecules APIs including corticosteroids

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GDUFA

DMF Review : Complete

Rev. Date : 2016-08-15

Pay. Date : 2016-03-28

DMF Number : 30336

Submission : 2016-03-14

Status : Active

Type : II

Minakem Delmar

04

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Virtual BoothMetrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 35518

Submission : 2020-12-30

Status : Active

Type : II

Metrochem

05

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Virtual BoothAarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.

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GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 35969

Submission : 2021-07-01

Status : Active

Type : II

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Virtual BoothNeuland Laboratories- A dedicated 100% API provider.

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GDUFA

DMF Review : Complete

Rev. Date : 2018-07-16

Pay. Date : 2018-06-13

DMF Number : 32422

Submission : 2018-01-31

Status : Active

Type : II

Neuland

07

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Virtual BoothNeuland Laboratories- A dedicated 100% API provider.

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GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 39444

Submission : 2024-01-31

Status : Active

Type : II

Neuland

08

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Virtual BoothHonour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.

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GDUFA

DMF Review : Complete

Rev. Date : 2016-07-05

Pay. Date : 2016-04-26

DMF Number : 30461

Submission : 2016-05-18

Status : Active

Type : II

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Pharmex
Not Confirmed

09

Pharmex
Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2015-12-18

Pay. Date : 2014-12-24

DMF Number : 29660

Submission : 2015-09-30

Status : Active

Type : II

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Pharmex
Not Confirmed

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Pharmex
Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2015-11-13

Pay. Date : 2015-09-23

DMF Number : 28009

Submission : 2014-02-26

Status : Active

Type : II

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JDMF

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Pharmex
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Apixaban

Registration Number : 307MF10036

Registrant's Address : Alembic Road, Vadodara 390 003, Gujarat, India

Initial Date of Registration : 2025-02-19

Latest Date of Registration : 2025-02-19

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Pharmex
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Apixaban

Registration Number : 306MF10141

Registrant's Address : 25, Barangongdan-ro, Hyangnam-eup, Hwaseong-si, Gyeonggi-do, Korea

Initial Date of Registration : 2024-11-13

Latest Date of Registration : 2024-11-13

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EU WC

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Apixaban IH

Date of Issue : 2022-07-28

Valid Till : 2025-12-30

Written Confirmation Number : WC-0390

Address of the Firm : Devunipalavalasa Village, Ranasthalam Mandal, Srikakulam District -532409, Andhr...

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Apixaban IHS

Date of Issue : 2024-04-03

Valid Till : 2027-01-21

Written Confirmation Number : WC-0493

Address of the Firm : Unit-IV, Plot No: 34B, 40B & 60B, J.N. Pharma City, Thanam (V), Parawada (M), An...

Metrochem

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Apixaban IH

Date of Issue : 2022-08-24

Valid Till : 2025-07-29

Written Confirmation Number : WC-0099

Address of the Firm : Plot No.E-50, 50/1 and 59/1, Unit ?IV, MIDC, Tarapur?401506, Taluka: Palghar, Di...

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Apixaban IH

Date of Issue : 2022-06-07

Valid Till : 2025-06-16

Written Confirmation Number : WC-0037

Address of the Firm : Unit II Plot No. 92-94, 257-259, IDA, Pashamylaram, Isnapur Village, Patancheru ...

Neuland

05

Pharmex
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Apixaban

Date of Issue : 2022-06-17

Valid Till : 2025-02-07

Written Confirmation Number : WC-0082

Address of the Firm : Karakhadi Plot No. 842-843, At - Karakhdi, Tal. - Padra, Dist - Vadodara 391 450...

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06

Pharmex
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Apixaban IH

Date of Issue : 2022-07-06

Valid Till : 2025-06-25

Written Confirmation Number : WC-0057n

Address of the Firm : Plot No. 3109, GIDC, Industrial Estate Ankleshwar, Distt- Bharuch - 393002, Guja...

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Pharmex
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Apixaban IH

Date of Issue : 2022-06-09

Valid Till : 2025-12-08

Written Confirmation Number : WC-0077

Address of the Firm : Block No. 422, ECP Canal Road Village - Luna, Tal - Padra, Dist - Vadodara GUjar...

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Pharmex
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Apixaban IH

Date of Issue : 2022-06-06

Valid Till : 2025-06-10

Written Confirmation Number : WC-0017

Address of the Firm : Unit-II, SurveyNo.:10&13,Gaddapotharam (Village), IDA-Kazipally, Jinnaram (Manda...

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Biocon

India
Pharmex
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Biocon

India
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Apixaban IHS

Date of Issue : 2022-06-07

Valid Till : 2025-04-08

Written Confirmation Number : WC-0038n

Address of the Firm : Plot no. 213-215 & 216/B, IDA Phase II, Pashamylaram, Sangareddy (District), Tel...

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Pharmex
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Apixaban

Date of Issue : 2022-06-17

Valid Till : 2025-07-14

Written Confirmation Number : WC-0021n

Address of the Firm : Sy. Nos: 317, 320, 321, 322, 323, 604 & 605, Rudraram (Village), Patancheru (Man...

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KDMF

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Polpharma

Poland
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Apixaban

Registrant Name : IMCD Korea Co., Ltd.

Registration Date : 2020-08-05

Registration Number : Su172-5-ND

Manufacturer Name : Zakłady Farmaceutyczne Polp...

Manufacturer Address : ul. Peplińska 19, 83-200 Starogard Gdański, POLAND

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Polpharma

Poland
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Apixaban

Registrant Name : Wooshin Labotech Co., Ltd.

Registration Date : 2020-09-04

Registration Number : No. 172-5-ND(1)

Manufacturer Name : Pharmaceutical Works Polphar...

Manufacturer Address : 19. Pelplinska Str, 83-200 Starogard Gdanski, Poland

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

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Apixaban

Registrant Name : Pami Future Co., Ltd.

Registration Date : 2018-01-30

Registration Number : No. 574-11-ND

Manufacturer Name : Dr. Reddy's Laboratories Lim...

Manufacturer Address : CTO-SEZ Process Unit-01, Sector No.'s 28 to 34, 36 to 37, 40, 50 to 53 & 03, Survey N...

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Apixaban

Registrant Name : Pami Future Co., Ltd.

Registration Date : 2019-01-17

Registration Number : No. 574-12-ND

Manufacturer Name : Dr. Reddy's Laboratories Lim...

Manufacturer Address : CTO-SEZ Process Unit-01, Sector No. 28 & 34, Devunipalavalasa Village, Srikakulam Dis...

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Virtual BoothNeuland Laboratories- A dedicated 100% API provider.

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Apixaban

Registrant Name : Aging Life Science Co., Ltd.

Registration Date : 2021-11-04

Registration Number : 434-42-ND

Manufacturer Name : Neuland Laboratories Limited

Manufacturer Address : Plot No. 92-94, 257-259 IDA, Pashamylaram, Isnapur Village, Patancheru Mandal, Sangar...

Neuland

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Honour Lab

India
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Apixaban

Registrant Name : Hwail Pharmaceutical Co., Ltd.

Registration Date : 2017-07-25

Registration Number : Su331-9-ND

Manufacturer Name : M/s. Honor Lab Limited (Unit...

Manufacturer Address : Unit-III, Plot No.4, Hetero Infrastructure Ltd., SEZ, N.Narasapuram Village, Nakkapal...

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Honour Lab

India
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Apixaban

Registrant Name : Lee Sung International Co., Ltd.

Registration Date : 2020-05-04

Registration Number : Su331-9-ND(2)

Manufacturer Name : Honour Lab Limited(Unit-III)

Manufacturer Address : Unit-III, Plot No.4, Hetero Infrastructure Ltd., SEZ, N.Narasapuram Village, Nakkapal...

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Honour Lab

India
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Apixaban

Registrant Name : Pharmapia Co., Ltd.

Registration Date : 2018-05-03

Registration Number : Su331-9-ND(1)

Manufacturer Name : M/s. Honor Lab Limited (Unit...

Manufacturer Address : Unit-III, Plot No.4, Hetero Infrastructure Ltd., SEZ, N.Narasapuram Village, Nakkapal...

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Apixaban (undifferentiated)

Registrant Name : Sungwoo Chemical Co., Ltd.

Registration Date : 2024-07-25

Registration Number : 473-31-ND

Manufacturer Name : Alembic Pharmaceuticals Limi...

Manufacturer Address : API Division Karakhadi, Plot No. 842-843 Tal-Padra, AT.- Karakhadi-391 450, Dist.- Va...

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Apixaban (undifferentiated)

Registrant Name : Samoh Pharmaceutical Co., Ltd.

Registration Date : 2024-07-25

Registration Number : Number 207-67-ND

Manufacturer Name : Morepen Laboratories Limited

Manufacturer Address : (Morepen Village)Vill. Malkumajra, Baddi-Nalagarh Road, Baddi. District-Solan (Himach...

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Listed Suppliers

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Polpharma

Poland
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Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

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Apixaban

About the Company : Polpharma API, part of a leading Polish pharmaceutical group, has over 70 years of experience in process development and cGMP manufacturing. We offer end-to-end solutions, from API...

Polpharma API, part of a leading Polish pharmaceutical group, has over 70 years of experience in process development and cGMP manufacturing. We offer end-to-end solutions, from API development to scale-up, at our FDA-approved plant in Central Europe. Our expert team provides high-quality, tailor-made services for small molecule API clinical candidates, with strong regulatory support and world-class facilities. Trusted by global partners, we specialize in complex chemical processes and deliver exceptional customer experiences. Polpharma API – Your reliable European CDMO partner.
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Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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Apixaban

About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...

Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provides high-quality, low-cost APIs to leading pharma companies in 80+ countries. It has 8 USFDA-inspected facilities – 6 in India & 1 each in Mexico & the UK & are inspected by international regulatory authorities on a regular basis. Its facilities are supplemented by formulation facilities that provide a wide range of dosage forms. Product(s) under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act and not for commercial sale
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Minakem

France
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Virtual BoothMinakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.

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Apixaban

About the Company : MINAKEM is a cGMP custom manufacturer of small molecule API, HPAPI and steroids. All development and manufacturing activities are supported by highly skilled R&D teams, supported b...

MINAKEM is a cGMP custom manufacturer of small molecule API, HPAPI and steroids. All development and manufacturing activities are supported by highly skilled R&D teams, supported by strong analytical and regulatory affairs services. The R&D team has an expertise in process development, organic synthesis, and works under a secrecy agreement to protect your IP. With 3 production sites in Europe and 1 in Canada, Minakem is ready to support your strategic sourcing projects or your reshoring activities. Recently launched commercial generic API: Apixaban, Mirabegron, Fulvestrant, remifentanil, esmolol,
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DKSH

Switzerland
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Virtual BoothDKSH is your trusted partner for companies looking to grow their business in Asia & beyond.

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Apixaban

About the Company : DKSH, founded with the goal of improving people's lives, assists businesses with market expansion and business growth in both existing and emerging markets. It has been fostering g...

DKSH, founded with the goal of improving people's lives, assists businesses with market expansion and business growth in both existing and emerging markets. It has been fostering growth for businesses in Asia and beyond for over 155 years. DKSH operates in 36 markets, is listed on the SIX Swiss Exchange, employs 33,100 specialists, and generated net sales of CHF 11.1 billion in 2021. It is the leading global distributor of innovative pharma ingredients for pharmaceutical synthesis and formulation. It offers a range of products, ranging from animal care products to packaging materials, intermediates to nutraceuticals, and APIs to excipients.
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Virtual BoothMinakem is manufacturing small molecules APIs including corticosteroids

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Apixaban

About the Company : Minakem Montreal is developing and manufacturing small molecules APIs and advanced intermediates, including corticosteroids. Following efficient processes and methodologies, our em...

Minakem Montreal is developing and manufacturing small molecules APIs and advanced intermediates, including corticosteroids. Following efficient processes and methodologies, our employees operate a regularly inspected cGMP facility equipped with reactors ranging from 40 to 7,600 litres. Located in Montreal, Canada, we have contributed to the success of our North-American and international clients since 1964.
Minakem Delmar

06

LGM Pharma

U.S.A
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Virtual BoothLGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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Apixaban

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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07

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Virtual BoothMetrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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Apixaban

About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...

Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product groups and has been approved by ISO 9001-2015, USFDA, WHO GMP, Cofepris & Japanese authorities. Metrochem’s in-depth industry knowledge, & hi-tech & advanced infrastructure, helps it provide quality products to its customers. Note: None of the products will be supplied to the countries where this could conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer
Metrochem

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Virtual BoothRochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.

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Apixaban

About the Company : Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quali...

Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quality ingredients manufactured in China. Headquartered in the Hauppauge, New York, Rochem has 16 offices spread across the globe to cater to the needs of its customers. Rochem’s operations are fully cGMP compliant and has been audited by the USFDA as well as several multinational organizations. It also trains and audits its partners to ensure all of their technologies and systems are FDA-compliant.
Rochem

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  • EDQM
  • WHO-GMP

Virtual BoothIOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.

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Apixaban

About the Company : With a history spanning over three decades, IOL Chemicals and Pharmaceuticals Limited is an innovation-driven company that specializes in bulk drugs, intermediates and specialty ch...

With a history spanning over three decades, IOL Chemicals and Pharmaceuticals Limited is an innovation-driven company that specializes in bulk drugs, intermediates and specialty chemicals. As an API-based company, IOL Chemicals has substantial manufacturing capacities that provide economies of scale and cost advantages. It also has extensive expertise in specialty chemicals. IOL Chemicals’ API portfolio includes various therapeutic categories such as pain management, anti-diabetic, anti-hypertensive and anti-convulsant. IOL Chemicals is a backward-integrated company that produces all intermediates and key starting materials for ibuprofen.
IOL Chemicals

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  • EDQM
  • WHO-GMP

Virtual BoothJai Radhe Sales is your partner for all your sourcing needs.

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Apixaban

About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...

Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete sourcing solutions for pharmaceutical products from India, including technical and regulatory assistance. It believes in providing its customers with high-quality products at reasonable prices. It has always endeavored to achieve global standards in the field of pharmaceuticals and has carved out a niche for itself through new methods based on current market needs. Today, it has established itself as a truly global company, with exports to almost every continent.
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03-Jan-2022
23-May-2025
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Drugs in Development

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Details:

Eliquis-Generic (apixaban) is a factor Xa inhibitor anticoagulant indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.


Lead Product(s): Apixaban

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Eliquis-Generic

Study Phase: Approved FDFProduct Type: HPAPI

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable May 08, 2021

Breckenridge Pharmaceutical

01

Details : Eliquis-Generic (apixaban) is a factor Xa inhibitor anticoagulant indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

Product Name : Eliquis-Generic

Product Type : HPAPI

Upfront Cash : Inapplicable

May 08, 2021

Breckenridge Pharmaceutical

Details:

Apixaban Tiefenbacher (apixaban) is a factor Xa inhibitor, anticoagulant small molecule drug. It is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.


Lead Product(s): Apixaban

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Apixaban Tiefenbacher

Study Phase: Approved FDFProduct Type: HPAPI

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable October 20, 2022

Tiefenbacher Compnay Banner

02

Lead Product(s) : Apixaban

Therapeutic Area : Cardiology/Vascular Diseases

Highest Development Status : Approved FDF

Partner/Sponsor/Collaborator : Inapplicable

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : Apixaban Tiefenbacher (apixaban) is a factor Xa inhibitor, anticoagulant small molecule drug. It is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

Product Name : Apixaban Tiefenbacher

Product Type : HPAPI

Upfront Cash : Inapplicable

October 20, 2022

Tiefenbacher Compnay Banner

Details:

TAH3311 (apixaban) is a factor Xa inhibitor, anticoagulant small molecule drug. It is being investigated for the treatment of thromboembolic conditions.


Lead Product(s): Apixaban

Therapeutic Area: Hematology Brand Name: TAH3311

Study Phase: Phase IIProduct Type: HPAPI

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable February 17, 2025

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Details : TAH3311 (apixaban) is a factor Xa inhibitor, anticoagulant small molecule drug. It is being investigated for the treatment of thromboembolic conditions.

Product Name : TAH3311

Product Type : HPAPI

Upfront Cash : Inapplicable

February 17, 2025

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Details:

TAH3311 (apixaban) is a factor Xa inhibitor, anticoagulant small molecule drug. It is being investigated for the treatment of thromboembolic conditions.


Lead Product(s): Apixaban

Therapeutic Area: Hematology Brand Name: TAH3311

Study Phase: Phase IIProduct Type: HPAPI

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable January 21, 2025

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Details : TAH3311 (apixaban) is a factor Xa inhibitor, anticoagulant small molecule drug. It is being investigated for the treatment of thromboembolic conditions.

Product Name : TAH3311

Product Type : HPAPI

Upfront Cash : Inapplicable

January 21, 2025

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Details:

TAH3311 is an ODF formulation of apixaban, a factor Xa inhibitor, widely recognized first-line treatment and gold standard for stroke prevention and thrombosis management.


Lead Product(s): Apixaban

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: TAH3311

Study Phase: Phase IIProduct Type: HPAPI

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable November 19, 2024

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Details : TAH3311 is an ODF formulation of apixaban, a factor Xa inhibitor, widely recognized first-line treatment and gold standard for stroke prevention and thrombosis management.

Product Name : TAH3311

Product Type : HPAPI

Upfront Cash : Inapplicable

November 19, 2024

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Details:

Apixaban is an oral, reversible, and selective active site inhibitor of FXa. Apixaban inhibits free and clot-bound FXa, and prothrombinase activity. By inhibiting FXa, apixaban decreases thrombin generation and thrombus development.


Lead Product(s): Apixaban

Therapeutic Area: Hematology Brand Name: Apixaban-Generic

Study Phase: Approved FDFProduct Type: HPAPI

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable February 28, 2023

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Details : Apixaban is an oral, reversible, and selective active site inhibitor of FXa. Apixaban inhibits free and clot-bound FXa, and prothrombinase activity. By inhibiting FXa, apixaban decreases thrombin generation and thrombus development.

Product Name : Apixaban-Generic

Product Type : HPAPI

Upfront Cash : Inapplicable

February 28, 2023

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Details:

It alleged that Micro Labs has already listed the apixaban product in 2.5 mg and 3 mg tablet strengths under the probable brand name Apivas on various third party websites and has also applied for registration of the trade mark Apivas before the Indian Trade Mark Registry.


Lead Product(s): Apixaban

Therapeutic Area: Hematology Brand Name: Eliquis

Study Phase: Approved FDFProduct Type: HPAPI

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 19, 2021

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Details : It alleged that Micro Labs has already listed the apixaban product in 2.5 mg and 3 mg tablet strengths under the probable brand name Apivas on various third party websites and has also applied for registration of the trade mark Apivas before the Indian T...

Product Name : Eliquis

Product Type : HPAPI

Upfront Cash : Inapplicable

August 19, 2021

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Details:

The Phase 3 clinical trials will analyse the use of Bristol Myers Squibb/Pfizer’s anticoagulant, Eliquis (apixaban 2.5mg) in patients discharged from the hospital following a diagnosis of moderate-to-severe Covid-19.


Lead Product(s): Apixaban

Therapeutic Area: Infections and Infectious Diseases Brand Name: Eliquis

Study Phase: Phase IIIProduct Type: HPAPI

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 03, 2021

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Details : The Phase 3 clinical trials will analyse the use of Bristol Myers Squibb/Pfizer’s anticoagulant, Eliquis (apixaban 2.5mg) in patients discharged from the hospital following a diagnosis of moderate-to-severe Covid-19.

Product Name : Eliquis

Product Type : HPAPI

Upfront Cash : Inapplicable

August 03, 2021

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Details:

HEAL-COVID will enrol patients when they are discharged from hospital, following their first admission for COVID-19. They will be randomised and given one of two drugs – apixaban and atorvastatin – and their progress tracked.


Lead Product(s): Apixaban

Therapeutic Area: Infections and Infectious Diseases Brand Name: Eliquis

Study Phase: Phase IIIProduct Type: HPAPI

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable March 25, 2021

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Details : HEAL-COVID will enrol patients when they are discharged from hospital, following their first admission for COVID-19. They will be randomised and given one of two drugs – apixaban and atorvastatin – and their progress tracked.

Product Name : Eliquis

Product Type : HPAPI

Upfront Cash : Inapplicable

March 25, 2021

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Details:

Apixaban is an anticoagulant, or blood thinner. It is used for patients with health problems caused by a blood clot.


Lead Product(s): Apixaban

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed

Study Phase: Approved FDFProduct Type: HPAPI

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable September 14, 2020

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Details : Apixaban is an anticoagulant, or blood thinner. It is used for patients with health problems caused by a blood clot.

Product Name : Undisclosed

Product Type : HPAPI

Upfront Cash : Inapplicable

September 14, 2020

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INTERMEDIATE SUPPLIERS

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01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothIOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.

CAS Number : 1267610-26-3

End Use API : Apixaban

About The Company : With a history spanning over three decades, IOL Chemicals and Pharmaceuticals Limited is an innovation-driven company that specializes in bulk drugs, intermedia...

IOL Chemicals

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothIOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.

CAS Number : 503615-03-0

End Use API : Apixaban

About The Company : With a history spanning over three decades, IOL Chemicals and Pharmaceuticals Limited is an innovation-driven company that specializes in bulk drugs, intermedia...

IOL Chemicals

03

PMC Isochem

France
  • fda
  • EDQM
  • WHO-GMP

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

CAS Number : 1575-61-7

End Use API : Apixaban

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

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothFaran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

CAS Number : 461432-25-7

End Use API : Apixaban

About The Company : Faran Shimi Pharmaceutical Company, established in 2001 and affiliated with Golrang Pharmaceutical Investment Co, manufactures high-quality Active Pharmaceutica...

Faran Shimi Pharmaceutical

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.

CAS Number : 1267610-26-3

End Use API : Apixaban

About The Company : Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, c...

Aarti Industries Company Banner

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.

CAS Number : 545445-44-1

End Use API : Apixaban

About The Company : Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, c...

Aarti Industries Company Banner

07

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothChynops Pharma is an ideal sourcing partner for high-quality APIs, advanced intermediates, speciality chemicals & excipients.

CAS Number : 540-37-4

End Use API : Apixaban

About The Company : Chynops Pharma, a company certified with ISO 9001:2015, is situated in Ahmedabad, India. We specialize in exporting, supplying, and trading a wide range of prod...

Chynops Pharma

08

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CAS Number : 27143-07-3

End Use API : Apixaban

About The Company : Actis Generics Pvt Ltd is a fast emerging APIs (Active Pharmaceutical Ingredients) & Intermediates manufacturer & supplier in India set up by a group of young p...

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CAS Number : 675-20-7

End Use API : Apixaban

About The Company : Established in 2003 with small pilot plant and came in to commercial production in 2013 in the name of Allchem Laboratories, it is an independent privately owne...

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CAS Number : 110-70-3

End Use API : Apixaban

About The Company : Established in 2003 with small pilot plant and came in to commercial production in 2013 in the name of Allchem Laboratories, it is an independent privately owne...

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Listed Dossiers

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01

  • fda
  • EDQM
  • WHO-GMP

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

Flag India
Digital Content Digital Content

Regulatory Info : Lead Market Dossiers- Filed

Registration Country : India

Apixaban

Brand Name :

Dosage Form : Oral Solid Dosage Form

Dosage Strength : 2.5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Lead Market Dossiers- Filed

Registration Country : India

Dr Reddy Company Banner

01

  • fda
  • EDQM
  • WHO-GMP

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

Flag India
Digital Content Digital Content

Packaging :

Regulatory Info : Lead Market Dossiers- Filed

Apixaban

Dosage : Oral Solid Dosage Form

Dosage Strength : 2.5MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Dr Reddy Company Banner

02

  • fda
  • EDQM
  • WHO-GMP

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

Flag India
Digital Content Digital Content

Regulatory Info : Lead Market Dossiers- Filed

Registration Country : India

Apixaban

Brand Name :

Dosage Form : Oral Solid Dosage Form

Dosage Strength : 5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Lead Market Dossiers- Filed

Registration Country : India

Dr Reddy Company Banner

02

  • fda
  • EDQM
  • WHO-GMP

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

Flag India
Digital Content Digital Content

Packaging :

Regulatory Info : Lead Market Dossiers- Filed

Apixaban

Dosage : Oral Solid Dosage Form

Dosage Strength : 5MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Dr Reddy Company Banner

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothWe are the TIEFENBACHER GROUP, Health Pioneers since 1963.

Flag Germany
Digital Content Digital Content

Regulatory Info : EU Dossier Readiness-Q4 2018

Registration Country : Germany

Apixaban

Brand Name :

Dosage Form : Tablet

Dosage Strength : 2.5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : EU Dossier Readiness-Q4 2018

Registration Country : Germany

Tiefenbacher Compnay Banner

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothWe are the TIEFENBACHER GROUP, Health Pioneers since 1963.

Flag Germany
Digital Content Digital Content

Packaging :

Regulatory Info : EU Dossier Readiness-Q4 2018

Apixaban

Dosage : Tablet

Dosage Strength : 2.5MG

Brand Name :

Approval Date :

Application Number :

Registration Country : Germany

Tiefenbacher Compnay Banner

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothWe are the TIEFENBACHER GROUP, Health Pioneers since 1963.

Flag Germany
Digital Content Digital Content

Regulatory Info : EU Dossier Readiness-Q4 2018

Registration Country : Germany

Apixaban

Brand Name :

Dosage Form : Tablet

Dosage Strength : 5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : EU Dossier Readiness-Q4 2018

Registration Country : Germany

Tiefenbacher Compnay Banner

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothWe are the TIEFENBACHER GROUP, Health Pioneers since 1963.

Flag Germany
Digital Content Digital Content

Packaging :

Regulatory Info : EU Dossier Readiness-Q4 2018

Apixaban

Dosage : Tablet

Dosage Strength : 5MG

Brand Name :

Approval Date :

Application Number :

Registration Country : Germany

Tiefenbacher Compnay Banner

05

Bal Pharma

India
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothBal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Apixaban

Brand Name : Apixaban

Dosage Form : Tablet

Dosage Strength : 5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

BalPharma

05

Bal Pharma

India
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothBal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.

Flag India
Digital Content Digital Content

Packaging :

Regulatory Info :

Apixaban

Dosage : Tablet

Dosage Strength : 5MG

Brand Name : Apixaban

Approval Date :

Application Number :

Registration Country : India

BalPharma

06

Bal Pharma

India
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothBal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Apixaban

Brand Name : Apixaban

Dosage Form : Tablet

Dosage Strength : 2.5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

BalPharma

06

Bal Pharma

India
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothBal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.

Flag India
Digital Content Digital Content

Packaging :

Regulatory Info :

Apixaban

Dosage : Tablet

Dosage Strength : 2.5MG

Brand Name : Apixaban

Approval Date :

Application Number :

Registration Country : India

BalPharma

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Apixaban

Brand Name : Xanza

Dosage Form : Coated Tablet

Dosage Strength : 2.5MG

Packaging : 15/30 Tabs

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Argentina

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Apixaban

Dosage : Coated Tablet

Dosage Strength : 2.5MG

Brand Name : Xanza

Approval Date :

Application Number :

Registration Country : Argentina

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Medichem S.A

Spain
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Medichem S.A

Spain
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Apixaban

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Spain

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Medichem S.A

Spain
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Medichem S.A

Spain
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Apixaban

Dosage : Film Coated Tablet

Dosage Strength : 5MG

Brand Name :

Approval Date :

Application Number :

Registration Country : Spain

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Apixaban

Brand Name :

Dosage Form : Tablet

Dosage Strength : 5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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Apixaban

Dosage : Tablet

Dosage Strength : 5MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

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Apixaban

Brand Name :

Dosage Form : Tablet

Dosage Strength : 5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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Apixaban

Dosage : Tablet

Dosage Strength : 5MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

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DATA COMPILATION #PharmaFlow

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STOCK RECAP #PipelineProspector

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Pipeline Prospector Oct 2024: Lundbeck acquires Longboard for US$ 2.6 bn; molecular glue degrader tech witnesses dealmaking
In October, several pharma companies posted their third quarter (Q3) results. Drugmakers like Pfizer, BMS, Roche, Novartis, Sanofi, Merck and Incyte reported higher-than-expected Q3 earnings, beating analyst expectations. Despite these healthy results, pharma indices continued on their downward journey that had begun in September. The Nasdaq Biotechnology Index (NBI) dropped 2.6 percent from 4,771.85 to 4,650.07. The SPDR S&P Biotech ETF (XBI) fell 1.6 percent from 98.61 to 97.03, and the S&P Biotechnology Select Industry Index (SPSIBI) decreased 1.9 percent from 7,707.4 to 7,561.29.  Access the Pipeline Prospector Dashboard for October 2024 Newsmakers (Free Excel) Lundbeck buys Longboard, AbbVie picks up Aliada, Merck acquires Modifi in US$ 1 bn+ deals In mergers and acquisitions, Denmark’s Lundbeck agreed to buy California-based Longboard Pharmaceuticals for US$ 2.6 billion. The acquisition centers around bexicaserin, a promising phase 3 candidate for rare epilepsies including Dravet syndrome and Lennox-Gastaut syndrome, with Lundbeck projecting potential peak sales of US$ 1.5 billion to US$ 2 billion for this asset.  AbbVie acquired Boston-based Aliada Therapeutics for US$ 1.4 billion after reportedly outbidding at least three other drugmakers. The acquisition brings innovative blood-brain barrier technology to AbbVie’s portfolio, along with ALIA-1758, a phase 1 compound showing potential as a best-in-class therapy for Alzheimer’s disease. AbbVie also partnered with EvolveImmune Therapeutics in a potential US$ 1.4 billion deal (plus US$ 65 million upfront) to develop next-generation cancer biotherapeutics. The collaboration will leverage EvolveImmune’s innovative T-cell engager platform to create multispecific biologics targeting various oncology indications. Merck bolstered its oncology pipeline through the acquisition of Modifi Biosciences in a deal valued up to US$ 1.3 billion. The acquisition targets novel DNA modification therapeutics for challenging brain tumors, particularly glioblastomas. Merck  also entered into a potential US$ 1.9 billion deal with Mestag Therapeutics to explore fibroblast therapies for inflammatory diseases, leveraging Mestag’s innovative platform.  Access the Pipeline Prospector Dashboard for October 2024 Newsmakers (Free Excel) Pfizer, Novartis, Biogen sign molecular glue degrader deals; Astra in US$ 2 bn pact with CSPC There were at least three deals signed in October in the molecular glue degrader technology space. These degraders represent a novel therapeutic approach by facilitating the degradation of disease-causing proteins that are otherwise difficult to target with conventional drugs. First, Pfizer partnered Triana Biomedicines in a deal potentially exceeding US$ 1.5 billion, focusing on cancer applications. Second, Novartis committed US$ 150 million upfront to Monte Rosa Therapeutics in a deal worth up to US$ 2.25 billion. And Biogen tied up with Neomorph, pledging up to US$ 1.45 billion for neurological and immunological applications. Among other deals, AstraZeneca entered into a US$ 2 billion licensing agreement with CSPC Pharmaceutical Group for a novel lipid-lowering therapy, while Recordati acquired global rights to Sanofi’s Enjaymo for US$ 825 million upfront, with additional milestone payments of up to US$ 250 million. The Recordati-Sanofi deal focuses on cold agglutinin disease (CAD), a rare autoimmune disorder, and includes rights to sutimlimab, the first and only targeted therapy for CAD patients. Roche demonstrated its commitment to gene therapy advancement by expanding its collaboration with Dyno Therapeutics, committing over US$ 1 billion for adeno-associated virus (AAV) vector development, with an upfront payment of US$ 50 million. This expanded partnership builds on their initial 2020 collaboration and aims to accelerate the development of innovative gene therapies for neurological diseases.  Access the Pipeline Prospector Dashboard for October 2024 Newsmakers (Free Excel) AbbVie wins FDA nod for subcutaneous Parkinson’s drug; Roche med okayed for breast cancer October marked significant advances in the treatment of several major diseases. FDA approved AbbVie’s Vyalev for advanced Parkinson’s disease. This innovative therapy, utilizing foscarbidopa and foslevodopa prodrugs, delivers round-the-clock symptom control through subcutaneous infusion. The treatment represents a major advancement in managing motor fluctuations in late-stage patients, with market analysts projecting peak sales exceeding US$ 2 billion. In the oncology space, a historic milestone was reached with FDA’s approval of Vyloy, the world’s first therapy targeting CLDN18.2 proteins in gastric cancer. Developed by Astellas, the drug was approved for use in combination with chemotherapy for treating advanced gastric or gastroesophageal junction adenocarcinoma in adults with HER2-negative, CLDN18.2-positive tumors. This approval validates Astellas’ strategic US$ 1.4 billion acquisition of Ganymed Pharmaceuticals in 2016. Roche strengthened its position in breast cancer treatment with the approval of Itovebi, an oral PI3K inhibitor for first-line treatment of advanced hormone receptor-positive, HER2-negative breast cancer with PIK3CA mutation. This approval positions Itovebi as a strong competitor to existing treatments like Novartis' Piqray and AstraZeneca's Truqap, with Roche projecting annual peak sales of US$ 2.3 billion. Novartis expanded the reach of its leukemia treatment Scemblix through an accelerated approval for newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase. This expansion significantly increases the eligible patient population by approximately four times, building on its existing approval as a third-line treatment. Pfizer expanded its presence in the respiratory syncytial virus (RSV) market as FDA broadened the approval of Abrysvo to include at risk adults aged 18 to 50 years, making it the first and only RSV vaccine authorized for this population. In hematology, Pfizer secured approval for Hympavzi marking its second hemophilia approval in six months. This approval follows the earlier authorization of Pfizer’s one-time gene therapy Beqvez for hemophilia B in April. Iterum Therapeutics received FDA approval for its new oral antibiotic, Orlynvah, designed to treat uncomplicated urinary tract infections (uUTIs) in adult women who have limited or no alternative oral antibacterial treatment options. This marks the first US approval for an oral penem antibiotic.  Access the Pipeline Prospector Dashboard for October 2024 Newsmakers (Free Excel)  Gilead withdraws Trodelvy, J&J discontinues late-stage study of its bladder cancer candidate In a notable development for bladder cancer treatment, Gilead Sciences announced the withdrawal of Trodelvy from the US market after the targeted therapy, which received accelerated FDA approval in 2021 for metastatic urothelial cancer, failed to demonstrate survival benefits in a crucial confirmatory study.  Johnson & Johnson decided to discontinue the late-stage study of TAR-200, their investigational bladder cancer therapy, after interim analysis showed no superior benefits compared to standard chemo-radiation therapy. In neurology, Marinus Pharmaceuticals faced disappointment when their phase 3 trial of oral ganaxolone (Ztalmy) failed to meet its primary endpoint in reducing seizures associated with tuberous sclerosis complex (a genetic disorder). Marinus’ stock fell nearly 100 percent in October.  Access the Pipeline Prospector Dashboard for October 2024 Newsmakers (Free Excel)  Our view The last quarter was a good one for several drugmakers. Pfizer saw a surge in sales of its Covid drug Paxlovid to US$ 2.7 billion, encouraging it to up its guidance for Covid-related sales from US$ 8.5 billion to US$ 10.5 billion. For BMS, blockbusters like blood thinner Eliquis and cancer treatment Revlimid continued to bring in revenue. Merck’s growth was driven by the world’s top-selling drug, Keytruda, which saw revenue jump 17 percent compared to Q3 2023, beating analysts’ estimates. In a nutshell, the robust Q3 earnings of major pharma companies signals strong industry fundamentals, the volatility in pharma indices notwithstanding.  Access the Pipeline Prospector Dashboard for October 2024 Newsmakers (Free Excel)

Impressions: 3353

https://www.pharmacompass.com/pipeline-prospector-blog/pipeline-prospector-oct-2024-lundbeck-acquires-longboard-for-us-2-6-bn-molecular-glue-degrader-tech-witnesses-dealmaking

#PharmaFlow by PHARMACOMPASS
07 Nov 2024

NEWS #PharmaBuzz

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https://www.businesswire.com/news/home/20241108701311/en

BUSINESSWIRE
11 Nov 2024

https://www.indianpharmapost.com/news/bristol-myers-squibb-to-present-data-across-cardiovascular-portfolio-at-ecs-2024-16094

INDIANPHARMAPOST
27 Aug 2024

https://s28.q4cdn.com/781576035/files/doc_financials/2024/q2/Q2-2024-PFE-Earnings-Release.pdf

PRESS RELEASE
31 Jul 2024

https://www.fiercepharma.com/pharma/abecma-competition-sotyktu-pricing-pressure-and-ira-analysts-outline-bristol-myers-myriad

FIERCE PHARMA
12 Jul 2024

https://www.reuters.com/business/healthcare-pharmaceuticals/pfizers-longtime-science-chief-mikael-dolsten-step-down-2024-07-09/

REUTERS
09 Jul 2024

https://www.reuters.com/legal/jj-bristol-myers-lose-challenges-us-drug-price-negotiation-program-2024-04-29/

Brendan Pierson REUTERS
30 Apr 2024

Global Sales Information

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Annual Reports

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01

Brand Name : Eliquis

Apixaban

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EPS
Not Confirmed

Brand Name : Eliquis

U.S.A
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EPS
Not Confirmed

Apixaban

Main Therapeutic Indication : Cardiovascular Diseases

Currency : USD

2020 Revenue in Millions : 9,168

2019 Revenue in Millions : 7,929

Growth (%) : 16

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Brand Name : Eliquis

Apixaban

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EPS
Not Confirmed

Brand Name : Eliquis

U.S.A
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Apixaban

Main Therapeutic Indication : Cardiovascular Diseases

Currency : USD

2020 Revenue in Millions : 4,949

2019 Revenue in Millions : 4,220

Growth (%) : 17

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03

Brand Name : Eliquis

Apixaban

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Not Confirmed

Brand Name : Eliquis

U.S.A
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Not Confirmed

Apixaban

Main Therapeutic Indication : Cardiovascular Diseases

Currency : USD

2021 Revenue in Millions : 10,762

2020 Revenue in Millions : 9,168

Growth (%) : 17

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04

Brand Name : Eliquis

Apixaban

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Not Confirmed

Brand Name : Eliquis

U.S.A
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Apixaban

Main Therapeutic Indication : Cardiovascular Diseases

Currency : USD

2021 Revenue in Millions : 5,970

2020 Revenue in Millions : 4,949

Growth (%) : 21

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Brand Name : Eliquis

Apixaban

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Not Confirmed

Brand Name : Eliquis

U.S.A
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Apixaban

Main Therapeutic Indication : Cardiology/Vascular Diseases

Currency : USD

2022 Revenue in Millions : 6,480

2021 Revenue in Millions : 5,970

Growth (%) : 9

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Brand Name : Eliquis

Apixaban

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Brand Name : Eliquis

U.S.A
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Apixaban

Main Therapeutic Indication : Cardiology/Vascular Diseases

Currency : USD

2022 Revenue in Millions : 11,789

2021 Revenue in Millions : 10,762

Growth (%) : 10

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Brand Name : Eliquis

Apixaban

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Brand Name : Eliquis

U.S.A
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Apixaban

Main Therapeutic Indication : Cardiology/Vascular Diseases

Currency : USD

2023 Revenue in Millions : 12,206

2022 Revenue in Millions : 11,789

Growth (%) : 4

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Brand Name : Eliquis

Apixaban

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Not Confirmed

Brand Name : Eliquis

U.S.A
arrow
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Apixaban

Main Therapeutic Indication : Cardiology/Vascular Diseases

Currency : USD

2023 Revenue in Millions : 6,747

2022 Revenue in Millions : 6,480

Growth (%) : 4

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Brand Name : Eliquis

Apixaban

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EPS
Not Confirmed

Brand Name : Eliquis

U.S.A
arrow
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Apixaban

Main Therapeutic Indication : Cardiology/Vascular Diseases

Currency : USD

2024 Revenue in Millions : 13,333

2023 Revenue in Millions : 12,206

Growth (%) : 9

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Brand Name : Eliquis

Apixaban

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EPS
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Brand Name : Eliquis

U.S.A
arrow
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Apixaban

Main Therapeutic Indication : Cardiology/Vascular Diseases

Currency : USD

2024 Revenue in Millions : 7,366

2023 Revenue in Millions : 6,747

Growth (%) : 9

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Market Place

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Patents & EXCLUSIVITIES

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US Patents

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01

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BRISTOL

United Kingdom
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APIXABAN

US Patent Number : 6967208

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 220073

Patent Use Code : U-4180

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2026-11-21

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02

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BRISTOL

United Kingdom
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APIXABAN

US Patent Number : 11896586

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 220073

Patent Use Code : U-4180

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2040-11-22

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03

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BRISTOL

United Kingdom
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APIXABAN

US Patent Number : 6967208*PED

Drug Substance Claim :

Drug Product Claim :

Application Number : 220073

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2027-05-21

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APIXABAN

US Patent Number : 9326945

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 202155

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2031-02-24

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APIXABAN

US Patent Number : 6967208

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 202155

Patent Use Code : U-1302

Delist Requested :

Patent Use Description : TREATMENT OF PULMONARY...

Patent Expiration Date : 2026-11-21

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APIXABAN

US Patent Number : 6967208

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 202155

Patent Use Code : U-1502

Delist Requested :

Patent Use Description : PROPHYLAXIS OF PULMONA...

Patent Expiration Date : 2026-11-21

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APIXABAN

US Patent Number : 6967208

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 202155

Patent Use Code : U-1200

Delist Requested :

Patent Use Description : REDUCING THE RISK OF S...

Patent Expiration Date : 2026-11-21

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APIXABAN

US Patent Number : 6967208

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 202155

Patent Use Code : U-1501

Delist Requested :

Patent Use Description : PROPHYLAXIS OF DEEP VE...

Patent Expiration Date : 2026-11-21

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APIXABAN

US Patent Number : 6967208

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 202155

Patent Use Code : U-1323

Delist Requested :

Patent Use Description : REDUCING THE RISK OF S...

Patent Expiration Date : 2026-11-21

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APIXABAN

US Patent Number : 6967208

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 202155

Patent Use Code : U-4179

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2026-11-21

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US Exclusivities

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01

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BRISTOL

United Kingdom
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APIXABAN

Exclusivity Code : NP

Exclusivity Expiration Date : 2028-04-17

Application Number : 220073

Product Number : 1

Exclusivity Details :

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02

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BRISTOL

United Kingdom
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APIXABAN

Exclusivity Code : PED

Exclusivity Expiration Date : 2028-10-17

Application Number : 220073

Product Number : 1

Exclusivity Details :

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APIXABAN

Exclusivity Code : NPP

Exclusivity Expiration Date : 2028-04-17

Application Number : 202155

Product Number : 1

Exclusivity Details :

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04

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APIXABAN

Exclusivity Code : NPP

Exclusivity Expiration Date : 2028-04-17

Application Number : 202155

Product Number : 2

Exclusivity Details :

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05

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APIXABAN

Exclusivity Code : NS

Exclusivity Expiration Date : 2028-04-17

Application Number : 202155

Product Number : 3

Exclusivity Details :

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06

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APIXABAN

Exclusivity Code : PED

Exclusivity Expiration Date : 2028-10-17

Application Number : 202155

Product Number : 1

Exclusivity Details :

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07

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Not Confirmed
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APIXABAN

Exclusivity Code : PED

Exclusivity Expiration Date : 2028-10-17

Application Number : 202155

Product Number : 2

Exclusivity Details :

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08

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Not Confirmed
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APIXABAN

Exclusivity Code : PED

Exclusivity Expiration Date : 2028-10-17

Application Number : 202155

Product Number : 3

Exclusivity Details :

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ABOUT THIS PAGE

Looking for 503612-47-3 / Apixaban API manufacturers, exporters & distributors?

Apixaban manufacturers, exporters & distributors 1

49

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

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

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

API | Excipient name

Apixaban

Synonyms

503612-47-3, Eliquis, Bms-562247, Bms-562247-01, Bms 562247-01, 1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5,6,7-tetrahydro-1h-pyrazolo[3,4-c]pyridine-3-carboxamide

Cas Number

503612-47-3

Unique Ingredient Identifier (UNII)

3Z9Y7UWC1J

About Apixaban

Apixaban is an orally active inhibitor of coagulation factor Xa with anticoagulant activity. Apixaban directly inhibits factor Xa, thereby interfering with the conversion of prothrombin to thrombin and preventing formation of cross-linked fibrin clots.

BMS-562247-01, Apixaban Manufacturers

A BMS-562247-01, Apixaban manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of BMS-562247-01, Apixaban, including repackagers and relabelers. The FDA regulates BMS-562247-01, Apixaban manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. BMS-562247-01, Apixaban 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 BMS-562247-01, Apixaban manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

BMS-562247-01, Apixaban Suppliers

A BMS-562247-01, Apixaban supplier is an individual or a company that provides BMS-562247-01, Apixaban active pharmaceutical ingredient (API) or BMS-562247-01, Apixaban finished formulations upon request. The BMS-562247-01, Apixaban suppliers may include BMS-562247-01, Apixaban API manufacturers, exporters, distributors and traders.

click here to find a list of BMS-562247-01, Apixaban suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

BMS-562247-01, Apixaban USDMF

A BMS-562247-01, Apixaban DMF (Drug Master File) is a document detailing the whole manufacturing process of BMS-562247-01, Apixaban active pharmaceutical ingredient (API) in detail. Different forms of BMS-562247-01, Apixaban DMFs exist exist since differing nations have different regulations, such as BMS-562247-01, Apixaban USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A BMS-562247-01, Apixaban DMF submitted to regulatory agencies in the US is known as a USDMF. BMS-562247-01, Apixaban USDMF includes data on BMS-562247-01, Apixaban's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The BMS-562247-01, Apixaban USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of BMS-562247-01, Apixaban suppliers with USDMF on PharmaCompass.

BMS-562247-01, Apixaban JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The BMS-562247-01, Apixaban Drug Master File in Japan (BMS-562247-01, Apixaban JDMF) empowers BMS-562247-01, Apixaban API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the BMS-562247-01, Apixaban JDMF during the approval evaluation for pharmaceutical products. At the time of BMS-562247-01, Apixaban JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of BMS-562247-01, Apixaban suppliers with JDMF on PharmaCompass.

BMS-562247-01, Apixaban KDMF

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

Pharmaceutical companies submit a BMS-562247-01, Apixaban Drug Master File in Korea (BMS-562247-01, Apixaban KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of BMS-562247-01, Apixaban. The MFDS reviews the BMS-562247-01, Apixaban KDMF as part of the drug registration process and uses the information provided in the BMS-562247-01, Apixaban KDMF to evaluate the safety and efficacy of the drug.

After submitting a BMS-562247-01, Apixaban KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their BMS-562247-01, Apixaban API can apply through the Korea Drug Master File (KDMF).

click here to find a list of BMS-562247-01, Apixaban suppliers with KDMF on PharmaCompass.

BMS-562247-01, Apixaban WC

A BMS-562247-01, Apixaban written confirmation (BMS-562247-01, Apixaban WC) is an official document issued by a regulatory agency to a BMS-562247-01, Apixaban manufacturer, verifying that the manufacturing facility of a BMS-562247-01, Apixaban active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting BMS-562247-01, Apixaban APIs or BMS-562247-01, Apixaban finished pharmaceutical products to another nation, regulatory agencies frequently require a BMS-562247-01, Apixaban WC (written confirmation) as part of the regulatory process.

click here to find a list of BMS-562247-01, Apixaban suppliers with Written Confirmation (WC) on PharmaCompass.

BMS-562247-01, Apixaban 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 BMS-562247-01, Apixaban as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for BMS-562247-01, Apixaban 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 BMS-562247-01, Apixaban 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 BMS-562247-01, Apixaban and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a BMS-562247-01, Apixaban NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of BMS-562247-01, Apixaban suppliers with NDC on PharmaCompass.

BMS-562247-01, Apixaban GMP

BMS-562247-01, Apixaban 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 BMS-562247-01, Apixaban 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 BMS-562247-01, Apixaban GMP manufacturer or BMS-562247-01, Apixaban GMP API supplier for your needs.

BMS-562247-01, Apixaban CoA

A BMS-562247-01, Apixaban CoA (Certificate of Analysis) is a formal document that attests to BMS-562247-01, Apixaban's compliance with BMS-562247-01, Apixaban specifications and serves as a tool for batch-level quality control.

BMS-562247-01, Apixaban CoA mostly includes findings from lab analyses of a specific batch. For each BMS-562247-01, Apixaban 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.

BMS-562247-01, Apixaban may be tested according to a variety of international standards, such as European Pharmacopoeia (BMS-562247-01, Apixaban EP), BMS-562247-01, Apixaban JP (Japanese Pharmacopeia) and the US Pharmacopoeia (BMS-562247-01, Apixaban 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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