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Xarelto (Rivaroxaban) API Manufacturers & Suppliers

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Commercial-scale Suppliers

Producer
Produced in  Poland
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Employees: 455+

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USDMF
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EDMF/ASMF
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MSDS

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CoA
Distributor
Produced in  China
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Employees: 50+

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CEP
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MSDS
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ISO9001

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CoA
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Producer
Produced in  India
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Employees: 2000+

|
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FDA
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CEP
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USDMF
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EDMF/ASMF

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WC
CoA
Distributor
Produced in  India
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Employees: 10

|
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FDA
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MSDS
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BSE/TSE
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CoA

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CoA
Producer
Produced in  China
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Employees: 10+

|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
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USDMF
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MSDS
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BSE/TSE
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CoA

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MSDS
BSE/TSE
CoA
Producer
Produced in  Spain
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Employees: 475

|
Audit Report: Click here for more information on Eurofins audit reports
Certifications: GMP
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FDA
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CEP
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USDMF
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ISO9001

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GMP
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CEP
USDMF
ISO9001
CoA
GDP
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Producer
Produced in  Turkey
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Employees: 100+

|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
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USDMF
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MSDS
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WC
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CoA

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WC
CoA
Producer
Produced in  India
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Employees: 10k+

|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
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CEP
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USDMF
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MSDS
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BSE/TSE

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CEP
USDMF
MSDS
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CoA
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Distributor
Produced in  World
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Employees: +250

|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
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CoA

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CoA
Distributor
Produced in  India
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Employees: 25

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Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
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FDA
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MSDS
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BSE/TSE
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ISO9001

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MSDS
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ISO9001
CoA
Distributor
Produced in  World
|

Employees: +250

|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
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CoA

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CoA
Producer
Produced in  India
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Employees: 19

|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
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FDA
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CoA

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FDA
CoA
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Producer
Produced in  India
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Employees: 1-5

|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
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FDA
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CEP
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MSDS
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BSE/TSE

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FDA
CEP
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BSE/TSE
CoA
Distributor
Produced in  United States
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Employees: 50+

|
Audit Report: Click here for more information on Eurofins audit reports
Certifications: GMP
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MSDS
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BSE/TSE
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ISO9001
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CoA

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GMP
MSDS
BSE/TSE
ISO9001
CoA
Distributor
Produced in  China
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Employees: 50+

|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
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FDA
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CEP
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USDMF
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MSDS

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GMP
FDA
CEP
USDMF
MSDS
BSE/TSE
ISO9001
WC
CoA
Distributor
Produced in  Singapore
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Employees: 50+

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Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
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FDA
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CEP
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USDMF
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EDMF/ASMF

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GMP
FDA
CEP
USDMF
EDMF/ASMF
MSDS
BSE/TSE
ISO9001
JDMF
WC
KDMF
CoA
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€399,-
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Producer
Produced in  China
|

Employees: 500

|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: USDMF
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MSDS
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BSE/TSE
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CoA

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USDMF
MSDS
BSE/TSE
CoA
Distributor
Produced in  World
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Employees: 50

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Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
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USDMF
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MSDS
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JDMF
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KDMF

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GMP
USDMF
MSDS
JDMF
KDMF
CoA
ISO9001
Producer
Produced in  India
|

Employees: 250+

|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
|
FDA
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MSDS
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BSE/TSE
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CoA

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GMP
FDA
MSDS
BSE/TSE
CoA
Producer
Produced in  India
|

Employees: 4,000

|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
|
USDMF
|
MSDS
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WC
|
CoA

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GMP
USDMF
MSDS
WC
CoA
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€399,-
All Rivaroxaban data. Full access. Full negotiation power
Producer
Produced in  Spain
|
Audit Report: Click here for more information on Eurofins audit reports
Certifications: GMP
|
CoA

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GMP
CoA
Producer
Produced in  Spain
|
Audit Report: Click here for more information on Eurofins audit reports
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CoA

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GMP
CoA
Producer
Produced in  India
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Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
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USDMF
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WC
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CoA

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GMP
USDMF
WC
CoA
Producer
Produced in  India
|
Audit Report: Click here for more information on Eurofins audit reports
Certifications: USDMF
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CoA

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USDMF
CoA
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Producer
Produced in  Japan
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: CoA

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CoA
Distributor
Produced in  Unknown
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Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: coa

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coa
Producer
Produced in  Slovenia
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Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
|
CoA

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GMP
CoA
Producer
Produced in  India
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: USDMF
|
CoA

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USDMF
CoA
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€399,-
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Producer
Produced in  India
|

Employees: 21,650

|
Audit Report: Click here for more information on Eurofins audit reports
Certifications: GMP
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FDA
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CEP
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USDMF
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MSDS

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GMP
FDA
CEP
USDMF
MSDS
BSE/TSE
WC
CoA
Producer
Produced in  China
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
|
CoA

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GMP
CoA
Producer
Produced in  Hungary
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Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
|
CoA

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GMP
CoA
Producer
Produced in  China
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: USDMF
|
CoA

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USDMF
CoA
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€399,-
All Rivaroxaban data. Full access. Full negotiation power
Producer
Produced in  China
|
Audit Report: Click here for more information on Eurofins audit reports
Certifications: USDMF
|
WC
|
CoA

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USDMF
WC
CoA
Producer
Produced in  China
|
Audit Report: Click here for more information on Eurofins audit reports
Certifications: WC
|
CoA

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WC
CoA
Producer
Produced in  China
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
|
CoA

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GMP
CoA
Producer
Produced in  Unknown
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: USDMF
|
CoA

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USDMF
CoA
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€399,-
All Rivaroxaban data. Full access. Full negotiation power
Producer
Produced in  Malta
|
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Certifications: GMP
|
CoA

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GMP
CoA
Producer
Produced in  United States
|
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Certifications: GMP
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CoA

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GMP
CoA
Producer
Produced in  Unknown
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Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: USDMF
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CoA

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USDMF
CoA
Producer
Produced in  China
|
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Certifications: USDMF
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CoA

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USDMF
CoA
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Producer
Produced in  India
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
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CoA

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GMP
CoA
Producer
Produced in  India
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USDMF
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WC
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CoA

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GMP
USDMF
WC
CoA
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Producer
Produced in  India
|
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Certifications: FDA
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USDMF
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ISO
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coa
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EDQM certificate 2017

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coa
EDQM certificate 2017
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Producer
Produced in  Czech Republic
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CoA

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CoA
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Producer
Produced in  Malta
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CoA

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CoA
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Producer
Produced in  Spain
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CoA

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CoA
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Producer
Produced in  Unknown
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CoA

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Producer
Produced in  India
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Producer
Produced in  India
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WC

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Produced in  China
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Produced in  India
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WC
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CoA

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Rivaroxaban | CAS No: 366789-02-8 | GMP-certified suppliers

A medication that supports prevention and treatment of venous and arterial thromboembolic conditions, including postoperative VTE, atrial‑fibrillation–related stroke, DVT/PE, and pediatric VTE needs.

Therapeutic categories

AnticoagulantsAntithrombinsBCRP/ABCG2 SubstratesBlood and Blood Forming OrgansCytochrome P-450 CYP3A SubstratesCytochrome P-450 CYP3A4 Substrates
Generic name
Rivaroxaban
Molecule type
small molecule
CAS number
366789-02-8
DrugBank ID
DB06228
Approval status
Approved drug
ATC code
B01AF01

Primary indications

  • Rivaroxaban is indicated for the prevention of venous thromboembolic events (VTE) in patients who have undergone total hips replacements and total knee replacement surgery
  • Prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation
  • Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE)
  • To reduce risk of recurrent DVT and/or PE

Product Snapshot

  • Rivaroxaban is an oral small-molecule anticoagulant supplied mainly as tablets, capsules, and granules for suspension
  • It is used for VTE prevention and treatment, stroke prevention in nonvalvular atrial fibrillation, reduction of recurrent thromboembolic events, and cardiovascular risk reduction in select adult and pediatric populations
  • It is approved in major regulated markets including the US, EU, and Canada

Clinical Overview

Rivaroxaban (CAS 366789-02-8) is an orally active direct factor Xa inhibitor used for the prevention and treatment of thromboembolic disorders. It is classified as a phenylmorpholine derivative and was approved in 2011 as the first oral anticoagulant in its class. Clinical use includes prevention of venous thromboembolism following total hip or knee replacement surgery, prevention of stroke and systemic embolism in nonvalvular atrial fibrillation, and treatment and secondary prevention of deep vein thrombosis and pulmonary embolism. In combination with aspirin, it is also used to reduce major cardiovascular events in chronic coronary or peripheral artery disease. Pediatric indications include treatment and prevention of VTE from birth to 18 years of age and thromboprophylaxis after the Fontan procedure in patients at least 2 years old. Use is generally not recommended in severe renal impairment below 30 mL per minute.

Rivaroxaban produces anticoagulation by directly and competitively inhibiting free and clot‑associated factor Xa, preventing the conversion of prothrombin to thrombin and reducing fibrin formation. Its action disrupts the amplification phase of coagulation without requiring antithrombin III. The inhibition is functionally irreversible over the dosing interval. Although it prolongs aPTT and HepTest values in a dose‑dependent manner, these assays are not suitable for monitoring, and routine anti‑Xa testing is not recommended.

Absorption is dose dependent, with the 15 mg and 20 mg strengths requiring administration with food to optimize bioavailability, while the 10 mg dose can be taken without regard to meals. Rivaroxaban is a substrate of CYP3A, P‑glycoprotein, and BCRP, with mixed hepatic and renal elimination. Clinically relevant drug interactions may occur with strong inhibitors or inducers of these pathways. The absence of a routinely available reversal agent underscores the need for careful patient selection and bleeding risk assessment.

For API procurement, sourcing should prioritize verified manufacturers with robust control of impurities and particle‑size distribution, as these parameters influence oral absorption and regulatory compliance.

Identification & chemistry

Generic name Rivaroxaban
Molecule type Small molecule
CAS 366789-02-8
UNII 9NDF7JZ4M3
DrugBank ID DB06228

Pharmacology

SummaryRivaroxaban is an oral anticoagulant that selectively and competitively inhibits free and clot‑associated factor Xa, a central enzyme required for thrombin generation. By blocking factor Xa–mediated conversion of prothrombin to thrombin, it suppresses amplification of the coagulation cascade and limits fibrin clot formation. Its activity is direct and does not require antithrombin III.
Mechanism of actionRivaroxaban competitively inhibits free and clot bound factor Xa. Factor Xa is needed to activate prothrombin (factor II) to thrombin (factor IIa). Thrombin is a serine protease that is required to activate fibrinogen to fibrin, which is the loose meshwork that completes the clotting process. Since one molecule of factor Xa can generate more than 1000 molecules of thrombin, selective inhibitors of factor Xa are profoundly useful in terminating the amplification of thrombin generation. The action of rivaroxaban is irreversible.
PharmacodynamicsRivaroxaban is an anticoagulant which binds directly to factor Xa. Thereafter, it effectively blocks the amplification of the coagulation cascade, preventing the formation of thrombus. Rivaroxaban is a unqiue anticoagulant for two reasons. First of all, it is does not involve antithrombin III (ATIII) to exert its anticoagulant effects. Secondly, it is an oral agent whereas the widely used unfractionated heparin and low molecular weight heparins are for parenteral use only. Although the activated partial thromboplastin time (aPTT) and HepTest (a test developed to assay low molecular weight heparins) are prolonged in a dose-dependant manner, neither test is recommended for the assessment of the pharmacodynamic effects of rivaroxaban. Anti-Xa activity and inhibition of anti-Xa activity monitoring is also not recommended despite being influenced by rivaroxaban.
Targets
TargetOrganismActions
Coagulation factor XHumansantagonist

ADME / PK

AbsorptionFollowing oral administration, rivaroxaban is rapidly absorbed and reaches peak plasma concentration in 2-4 hours. Bioavailability of the 10 mg dose is >80%. However, the 15-20 mg dose have a lower bioavailability if taken in the fasted state and consequently should be taken with food.
Half-lifeThe terminal half life is 5-9 hours in adults and 11-13 hours in the elderly.
Protein bindingPlasma protein binding is about 92% to 95%
MetabolismApproximately two-thirds of the dose is metabolized. It is metabolized by CYP3A4, CYP3A5, CYP2J2 and CYP-independant mechanisms
Route of eliminationApproximately two-thirds of rivaroxaban is excreted into urine (via active tubular secretion in which approximately 36% as unchanged drug and 30% as inactive metabolism). The remaining third of the administered dose is excreted via feces in which 7% is in the form of unchanged drug and 21% as inactive metabolites.
Volume of distributionThe steady state Vd is 50 L
ClearanceSystemic clearance is approximately 10 L/h, so rivaroxaban is considered a drug with low clearance. Renal clearance is ~3-4 L/h.

Formulation & handling

  • Oral small‑molecule anticoagulant with low aqueous solubility, requiring solid‑dose designs that enhance dissolution and maintain consistent exposure.
  • Absorption is food‑sensitive at higher strengths, so formulation teams may account for fed‑state variability when developing oral products.
  • Stable as a solid API; handling focuses on controlling particle size and flow to ensure uniformity in tablets, capsules, and reconstitutable granules.

Regulatory status

LifecycleThe API is in a late‑stage lifecycle, with most patents expired and the final U.S. protection ending in early 2025. With products already marketed in Canada, the EU, and the U.S., the market landscape reflects a mature phase with potential for expanded generic entry.
MarketsCanada, EU, US
Supply Chain
Supply chain summaryRivaroxaban is supplied globally by a single originator developer, with branded and generic products present across the US, EU, and Canada. Multiple patents in Canada and the United States have already expired, and the remaining U.S. patent expires in early 2025, indicating that generic competition is already established in some markets and likely to expand further. This creates a diversified manufacturing landscape with multiple non‑originator suppliers entering post‑expiry.

Safety

ToxicityExcessive bleeding. Overdosages should be treated using activated charcoal and supportive measures such as mechanical compression and hemodynamic support. If bleeding is not controlled, the following procoagulants can be administered: activated prothrombin complex concentrate, prothrombin complex concentrate and recombinant factor VIIa. There is also a higher chance of post procedural hemorrhage compared to enoxaparin (1.55% vs. 1.39% respectively).
High Level Warnings:
  • High anticoagulant activity is associated with excessive bleeding risk, with reported post‑procedural hemorrhage rates slightly higher than enoxaparin
  • Overexposure may require specialized coagulation management due to potential for uncontrolled bleeding
  • Handling and development work should account for its potent inhibition of clot formation and associated hemodynamic impact in overdose scenarios

Rivaroxaban is a type of Antithrombotics


Antithrombotics, a subcategory of pharmaceutical active pharmaceutical ingredients (APIs), play a crucial role in preventing and treating thrombotic disorders, which are characterized by the formation of blood clots within blood vessels. These medications are essential in reducing the risk of thrombosis, such as deep vein thrombosis (DVT), pulmonary embolism (PE), and stroke, which can lead to severe health complications.

Antithrombotics exert their therapeutic effects through various mechanisms. One commonly used class of antithrombotics is anticoagulants, which inhibit the clotting process by interfering with the formation of blood clots. These drugs include heparin, warfarin, and direct oral anticoagulants (DOACs). They are administered to patients with conditions like atrial fibrillation, venous thromboembolism, or mechanical heart valves to prevent clot formation.

Another class of antithrombotics is antiplatelet agents, which prevent platelet aggregation, an essential step in blood clot formation. Aspirin, clopidogrel, and ticagrelor are well-known antiplatelet drugs used to prevent thrombosis in patients with coronary artery disease, ischemic stroke, or peripheral artery disease.

Antithrombotics are typically prescribed based on the individual patient's risk factors, medical history, and the specific thrombotic condition being treated. Dosage and administration instructions may vary depending on the drug's pharmacokinetic profile and desired therapeutic outcomes.

As with any medication, antithrombotics may have potential side effects, such as increased bleeding risk. Therefore, healthcare professionals carefully assess the patient's overall health status, including any underlying conditions, before prescribing these medications.

In conclusion, antithrombotics are a crucial subcategory of pharmaceutical APIs that play a vital role in preventing and treating thrombotic disorders. By inhibiting clot formation through various mechanisms, these medications significantly contribute to reducing the risk of serious complications associated with blood clots.


Rivaroxaban (Antithrombotics), classified under Anticoagulants


Anticoagulants are a vital category of pharmaceutical active pharmaceutical ingredients (APIs) used to prevent and treat blood clotting disorders. These medications play a crucial role in various medical conditions, including deep vein thrombosis (DVT), pulmonary embolism (PE), and atrial fibrillation (AF). Anticoagulants work by inhibiting the formation of blood clots or by preventing existing clots from getting larger.

There are different types of anticoagulants available, including direct thrombin inhibitors, vitamin K antagonists, and factor Xa inhibitors. Direct thrombin inhibitors, such as dabigatran, directly target the enzyme thrombin to hinder clot formation. Vitamin K antagonists, like warfarin, interfere with the production of clotting factors that rely on vitamin K. Factor Xa inhibitors, such as rivaroxaban and apixaban, inhibit the activity of factor Xa, a crucial component in the clotting cascade.

Anticoagulants are commonly prescribed to patients at risk of developing blood clots or those with existing clotting disorders. They are often used during surgeries, such as hip or knee replacements, to minimize the risk of post-operative clot formation. Patients with AF, a condition characterized by irregular heart rhythm, may also be prescribed anticoagulants to prevent stroke caused by blood clots.

While anticoagulants offer significant benefits in preventing and treating clot-related conditions, they also carry potential risks, including bleeding complications. Patients taking anticoagulants require careful monitoring to ensure the right dosage is administered, as excessive anticoagulation can lead to hemorrhage. Regular blood tests and close medical supervision are essential to manage the delicate balance between preventing clots and avoiding excessive bleeding.

In conclusion, anticoagulants are a crucial category of pharmaceutical APIs used to prevent and treat blood clotting disorders. They function by inhibiting clot formation or preventing existing clots from enlarging. While highly beneficial, their use requires careful monitoring to minimize the risk of bleeding complications.



Rivaroxaban API manufacturers & distributors

Compare qualified Rivaroxaban API suppliers worldwide. We currently have 50 companies offering Rivaroxaban API, with manufacturing taking place in 14 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.

SupplierTypeCountryProduct originCertificationsPortfolio
Producer
Japan Japan CoA76 products
Producer
Malta Malta CoA, GMP20 products
Producer
China China BSE/TSE, CoA, GMP, MSDS, USDMF229 products
Distributor
Singapore Singapore BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GMP, ISO9001, JDMF, KDMF, MSDS, USDMF, WC200 products
Distributor
China China BSE/TSE, CEP, CoA, FDA, GMP, ISO9001, MSDS, USDMF, WC250 products
Distributor
Germany World CoA, GMP, GDP, JDMF, KDMF, MSDS, USDMF243 products
Producer
India India BSE/TSE, CoA, FDA, GMP, MSDS52 products
Producer
Germany Unknown CoA, GMP, USDMF42 products
Producer
Italy United States CoA, GMP104 products
Producer
India India BSE/TSE, CEP, CoA, FDA, GMP, MSDS, USDMF, WC170 products
Producer
India India BSE/TSE, CEP, CoA, FDA, GMP, MSDS70 products
Producer
Czech Republic Czech Republic CoA, GMP19 products
Distributor
Germany Unknown CoA83 products
Producer
Hungary Hungary CoA, GMP48 products
Distributor
India India BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS484 products
Producer
Germany Unknown CoA, USDMF31 products
Producer
United Kingdom Unknown CoA, USDMF30 products
Producer
India India BSE/TSE, CEP, CoA, GMP, ISO9001, MSDS, USDMF52 products
Producer
Spain Spain CoA, GMP9 products
Producer
Slovenia Slovenia CoA, GMP81 products
Producer
India India CoA, GMP, USDMF, WC155 products
Producer
Spain Malta CoA, GMP39 products
Producer
China China CoA, GMP27 products
Producer
India India CoA, USDMF38 products
Producer
Spain Spain CoA, GMP50 products
Producer
India India BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GMP, ISO9001, MSDS, USDMF, WC22 products
Producer
India India CoA, GMP, USDMF, WC119 products
Producer
India India CoA, USDMF, WC44 products
Producer
Poland Poland BSE/TSE, CoA, EDMF/ASMF, FDA, GMP, KDMF, MSDS, USDMF64 products
Producer
China China CoA, WC33 products
Producer
Spain Spain CoA, GMP51 products
Producer
India India CoA, USDMF58 products
Distributor
United States United States BSE/TSE, CoA, GMP, ISO9001, MSDS144 products
Distributor
Jordan World CoA, GMP70 products
Producer
India India CoA, FDA, GMP515 products
Producer
China China BSE/TSE, CoA, MSDS, USDMF55 products
Distributor
China China CoA162 products
Distributor
China China CEP, CoA, GMP, ISO9001, MSDS, USDMF762 products
Producer
India India CoA, GMP12 products
Distributor
Spain Spain CEP, CoA, FDA, GDP, GMP, ISO9001, USDMF13 products
Producer
India India CoA, GMP, USDMF, WC28 products
Distributor
India India BSE/TSE, CoA, FDA, GMP, MSDS263 products
Producer
India India CoA, USDMF62 products
Producer
India India CoA, GMP, MSDS, USDMF, WC37 products
Producer
Turkey Turkey CoA, GMP, MSDS, USDMF, WC28 products
Producer
China China CoA, USDMF15 products
Producer
India India CoA, Other, FDA, ISO9001, USDMF30 products
Producer
China China CoA, GMP19 products
Producer
China China CoA, USDMF9 products
Producer
China China CoA, USDMF, WC13 products

When sending a request, specify which Rivaroxaban API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).

Use the list above to find high-quality Rivaroxaban API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.

Frequently asked questions about Rivaroxaban API


Sourcing

What matters most when sourcing GMP-grade Rivaroxaban?
Key considerations include verifying GMP compliance to meet Canada, EU, and US regulatory requirements and ensuring complete documentation for regulatory submissions. It is important to confirm that the supplier operates within the current patent landscape, as several patents have expired and remaining U.S. protection ends in early 2025. Assessing supply chain reliability is also essential given the shift from a single‑originator source to a more diversified post‑expiry manufacturing environment.
Which documents are typically required when sourcing Rivaroxaban API?
Request the core API documentation set: CoA (51 companies), GMP (36 companies), USDMF (27 companies), MSDS (17 companies), BSE/TSE (13 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Rivaroxaban API?
How can I request quotes for Rivaroxaban API from GMP suppliers?
Submit quote requests through the supplier listings with your specs and required documents (specifications, target volume, delivery timeline, and destination). Providing consistent details upfront speeds comparable offers and clarifies technical feasibility.
Is a GMP audit report available for Rivaroxaban manufacturers?
Audit reports may be requested for Rivaroxaban: 19 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Rivaroxaban API on Pharmaoffer?
Reported supplier count for Rivaroxaban: 51 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Rivaroxaban API?
Production countries reported for Rivaroxaban: India (18 producers), China (11 producers), Spain (4 producers). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Rivaroxaban usually hold?
Common certifications for Rivaroxaban suppliers: CoA (51 companies), GMP (36 companies), USDMF (27 companies), MSDS (17 companies), BSE/TSE (13 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.

Technical

What is Rivaroxaban (CAS 366789-02-8) used for?
Rivaroxaban is an oral direct factor Xa inhibitor used to prevent and treat venous and arterial thromboembolic disorders. It is indicated for prevention of venous thromboembolism after hip or knee replacement, prevention of stroke and systemic embolism in nonvalvular atrial fibrillation, and treatment and secondary prevention of deep vein thrombosis and pulmonary embolism. It is also used with aspirin to reduce major cardiovascular events in chronic coronary or peripheral artery disease, and in pediatric patients for treatment and prevention of VTE and for thromboprophylaxis after the Fontan procedure.
Which therapeutic class does Rivaroxaban fall into?
Rivaroxaban belongs to the following therapeutic categories: Anticoagulants, Antithrombins, BCRP/ABCG2 Substrates, Blood and Blood Forming Organs, Cytochrome P-450 CYP3A Substrates. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Rivaroxaban mainly prescribed for?
The primary indications for Rivaroxaban: Rivaroxaban is indicated for the prevention of venous thromboembolic events (VTE) in patients who have undergone total hips replacements and total knee replacement surgery, Prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), To reduce risk of recurrent DVT and/or PE. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Rivaroxaban work?
Rivaroxaban competitively inhibits free and clot bound factor Xa. Factor Xa is needed to activate prothrombin (factor II) to thrombin (factor IIa). Thrombin is a serine protease that is required to activate fibrinogen to fibrin, which is the loose meshwork that completes the clotting process. Since one molecule of factor Xa can generate more than 1000 molecules of thrombin, selective inhibitors of factor Xa are profoundly useful in terminating the amplification of thrombin generation. The action of Rivaroxaban is irreversible.
What should someone know about the safety or toxicity profile of Rivaroxaban?
Rivaroxaban’s principal safety concern is excessive bleeding due to its potent and sustained factor Xa inhibition, with post‑procedural hemorrhage rates reported as slightly higher than those seen with enoxaparin. Overexposure can lead to uncontrolled anticoagulation that may require specialized coagulation management, and no routinely available reversal agent is noted in the context. Strong interactions via CYP3A, P‑glycoprotein, or BCRP can alter exposure and further affect bleeding risk. Development and handling of the API should consider its high anticoagulant activity and potential hemodynamic effects in overdose scenarios.
What are important formulation and handling considerations for Rivaroxaban as an API?
Important considerations include managing its low aqueous solubility by using solid‑dose designs that promote adequate dissolution and consistent exposure. Because absorption of 15–20 mg doses is food‑sensitive, formulation teams may account for fed‑state effects when developing oral products. The API is stable as a solid, and handling typically focuses on controlling particle size and flow to ensure uniformity in tablets, capsules, or granules.
Is Rivaroxaban a small molecule?
Rivaroxaban is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Rivaroxaban?
Rivaroxaban is stable as a solid API, so chemical degradation is not a major concern under standard storage conditions. The main formulation‑related issue is its low aqueous solubility, which requires solid‑dose designs that promote adequate dissolution. Control of particle size and flow is important to maintain uniformity in tablets, capsules, or granules.

Regulatory

Where is Rivaroxaban approved or in use globally?
Rivaroxaban is reported as approved in the following major regions: Canada, EU, US. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for Rivaroxaban right now?
Rivaroxaban is authorized for use in Canada, the EU, and the US under their respective regulatory frameworks. Each region maintains its own requirements for manufacturing quality, safety, and post‑market monitoring. Patent protections and exclusivity periods are managed separately within these jurisdictions and follow their standard pharmaceutical intellectual‑property rules.

Pharmaoffer

How does Pharmaoffer’s Smart Sourcing Service help with Rivaroxaban procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Rivaroxaban. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Rivaroxaban included in the PRO Data Insights coverage?
PRO Data Insights coverage for Rivaroxaban: 2935 verified transactions across 770 suppliers and 415 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Rivaroxaban?
Market report availability for Rivaroxaban: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.