A Sourcing Guide: Choosing the Best Rivaroxaban API Manufacturers
A Sourcing Guide: Choosing the Best Rivaroxaban API Manufacturers
When sourcing Rivaroxaban API, pharmaceutical buyers must evaluate quality, compliance, scalability, documentation, and supplier credibility. India — especially Hyderabad’s advanced pharma clusters like Balanagar — has become the preferred destination for high-grade APIs manufactured under WHO-GMP and ICH-compliant conditions.
If you’re searching for trusted Rivaroxaban API manufacturers in India, Bio-Synth stands out for technical expertise, global export capability, and strong regulatory support.
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➡️ Rivaroxaban API Manufacturers & Suppliers in India
What Is Rivaroxaban and Why Is It in High Demand?
Rivaroxaban API is a direct oral anticoagulant (DOAC) used extensively to prevent and treat life-threatening clotting disorders.
Key Therapeutic Applications
- Prevention of stroke and embolism in non-valvular atrial fibrillation
- Treatment of deep vein thrombosis (DVT)
- Prevention of venous thromboembolism (VTE) after joint replacement surgeries
Since patent expiration, global demand for generic Rivaroxaban has increased dramatically leading pharma companies to seek reliable Rivaroxaban API suppliers in India that offer consistency, documentation, and scalable supply.
Why India Leads in Rivaroxaban API Production
India contributes nearly 20% of the world’s API exports. Hyderabad, known as the Bulk Drug Capital of India, houses WHO-GMP certified factories and highly trained chemists.
Advantages of Indian API Manufacturers
- Competitive pricing
- Robust regulatory compliance (WHO-GMP, CEP, USFDA audits)
- Skilled scientists and advanced chemistry talent
- Ability to supply commercial-scale volumes
- Integrated CDMO capabilities (intermediates + API)
With over USD 4.5 billion API exports in 2023, India remains a global API powerhouse.
What Makes a Top-Tier Rivaroxaban API Manufacturer?
1. Regulatory Certifications
Leading Rivaroxaban API manufacturers must hold:
- WHO-GMP / ISO certifications
- CEP / EDQM approvals for European markets
- USFDA or EU-GMP compliance (regulated market supply)
- Valid DMF submissions (US/EU/ROW)
2. Quality Parameters to Verify
Key technical attributes of Rivaroxaban API include:
- Purity ≥ 99.5%
- Controlled impurity profile
- Consistent particle size distribution
- Residual solvents compliant with ICH Q3C
3. Stability & Packaging
- 6-month accelerated stability
- 12-month long-term stability
- Moisture and oxidation-protected packaging
- HDPE drums with triple liner systems
4. Scalability & Manufacturing Capacity
Whether your requirement is 100 kg or multiple metric tons, top Rivaroxaban API suppliers must support:
- Continuous supply (no stockouts)
- Redundant production lines
- Proven commercial-scale delivery
5. Technical & CMC Support
Reliable suppliers provide:
- COAs, BMRs, and DMFs
- Impurity profiling
- Stability and validation documents
- Regulatory support for ANDA/CTD filings
Key Rivaroxaban API Specifications (Table)
| Parameter | Typical Requirement |
| Assay (HPLC) | ≥ 99.5% |
| Known Impurities | ≤ ICH Q3B limits |
| Particle Size (D90) | 10–20 microns |
| Polymorph Confirmation | PXRD / DSC |
| Residual Solvents | < ICH Q3C limits |
| Microbial Limits | < 10 CFU/g |
| Stability Studies | 6M Accelerated / 12M Long-Term |
Not All Rivaroxaban API Suppliers Are Equal — Choose Carefully
Some suppliers operate as traders rather than manufacturers, which may compromise quality and traceability.
Evaluate Suppliers On:
- Actual manufacturing capability
- Number of WHO-GMP / USFDA inspections
- Live DMF filings
- SOPs & OOS handling protocols
- Tech-transfer readiness
Why Hyderabad is a Strategic Hub for Rivaroxaban API Manufacturing
Hyderabad’s Balanagar region hosts 800+ bulk drug units supported by:
- Government-backed Pharma City initiatives
- R&D hubs (IICT, NIPER collaborations)
- Skilled chemists & GMP-trained workforce
- Quick global connectivity (Shamshabad Airport + national highways)
This ecosystem makes it the strongest base for Rivaroxaban API suppliers in India.
Bio-Synth: Reliable Partner for Rivaroxaban API Supply
With over 80 years of pharmaceutical excellence, Bio-Synth is recognized among top Rivaroxaban API manufacturers in India.
Core Strengths
- WHO-GMP and ISO-certified API units
- In-house production of key intermediates
- Expert chemistry team for impurity control
- Advanced analytical labs (HPLC, PXRD, DSC)
- Full regulatory and documentation support
Custom CDMO Services
Bio-Synth offers tailored solutions, including:
- Custom particle size (PSD)
- Polymorph control
- Dissolution profile adjustments
- Tech-transfer & formulation support
This helps brands reduce development risk and accelerate commercial launch.
Procurement Best Practices for Rivaroxaban API
Five-Step Sourcing Framework
- Define technical specifications
- Purity, PSD, impurity limits
- Evaluate shortlisted suppliers
- Site audits, GMP checks
- Request documentation
- CoA, DMF, CEP, analytical methods
- Pilot batch evaluation
- Dissolution, assay, impurity profiling
- Finalize commercial terms
- Pricing, MOQ, delivery, stability data
FAQs on Rivaroxaban API Procurement
1)Why do buyers prefer Indian Rivaroxaban API suppliers?
India offers cost-effective, WHO-GMP compliant manufacturing with deep technical specialization. Over 550+ DMFs filed in the US highlight its regulatory strength.
2)What certifications must a Rivaroxaban API supplier have?
WHO-GMP, CEP/EDQM, USFDA/EU-GMP (for regulated markets), stability data, COA, and DMF/CTD access.
3)Can particle size be customized?
Yes. High-level Rivaroxaban API manufacturers like Bio-Synth offer D90 customization (e.g., 20 microns) to match formulation needs.
Final Thoughts: Choose Trusted Rivaroxaban API Manufacturers in India
Sourcing Rivaroxaban API is not just procurement — it’s a strategic decision affecting regulatory success, formulation stability, and market entry timelines.
With strong chemistry expertise, WHO-GMP certification, and global supply chain strength, Bio-Synth remains one of the most reliable Rivaroxaban API manufacturers & suppliers in India.
Request Pricing & Bulk Quotes
Looking for Rivaroxaban API price in India, bulk orders, or regulatory documentation?
➡️ Contact Bio-Synth:
👉 https://bio-synth.in/contact/
Rivaroxaban API
Top Rivaroxaban API Manufacturers & Suppliers in India
Rivaroxaban API is an important pharmaceutical compound used as an oral anticoagulant to prevent and treat blood clots. It works by inhibiting Factor Xa, which helps prevent conditions like deep vein thrombosis, pulmonary embolism, and stroke in patients with atrial fibrillation. It is a key Active Pharmaceutical Ingredient (API) in the healthcare industry.
Product Description
Product Description
Name of the product: Rivaroxaban
Chemical Name : (S)-5-chloro-N-{[2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]oxazolidin-5-yl]methyl} thiophene-2-carboxamide
CAS Number: 366789-02-8
Molecular weight: 435.89 g/mol
Molecular formula: C19H18CIN3O5S
Category: Xa inhibitors
Therapeutic use: Anticoagulant used to prevent and treat blood clots
Usage: To reduce risk of conditions like deep vein thrombosis (DVT) and pulmonary embolism (PE)
Physical Form: Powder
Color: White or yellow
Package: As per requirement
Storage: Store in air-tight container below 30 deg C
Synonyms: 5-chloro-N-(((5S)-2-oxo-3-(4-(3-oxomorpholin-4-yl)phenyl)-1,3-oxazolidin-5-yl)methyl)thiophene-2-carboxamide
Solubility: Practically insoluble in water, freely soluble in dimethyl sulfoxide, practically insoluble in anhydrous ethanol and in heptanes
Specification
- Assay: 98.0% – 102.0% w/w (anhydrous substance)
- Total impurities: maximum 0.3%
- Unspecified impurity: maximum 0.1%
The Rivaroxaban API specification ensures that each batch of Rivaroxaban meets global quality standards. As one of the top Rivaroxaban API manufacturers in India, Bio-Synth adheres to strict guidelines to ensure product purity and properties.
Applications of Rivaroxaban API
- Rivaroxaban can help prevent strokes in patients with nonvalvular atrial fibrillation (NVAF) by helping to prevent clots from forming
- Rivaroxaban is used to treat blood clots in the veins of the legs (deep vein thrombosis or DVT) or lungs (pulmonary embolism or PE)
Therapeutic Uses and Indications
☐ Used to reduce the risk of blood clots from happening again in adults who continue to be at risk for DVT or PE after receiving treatment for blood clots for at least 6 months
☐ Used to help prevent a blood clot in the legs and lungs of adults who have just had hip or knee replacement surgery
☐ Used to help prevent blood clots in certain adults hospitalized for an acute illness and after discharge, who are at risk of getting blood clots because of the loss of or decreased mobility and other risks for getting blood clots, and who do not have a high risk of bleeding
It also has cardiovascular applications and is used with low dose aspirin to:
☐ Reduce the risk of serious heart problems, heart attack, and stroke in adults with coronary artery disease (a condition where the blood supply to the heart is reduced or blocked)
☐ Reduce the risk of a sudden decrease in blood flow to the legs, major amputation, serious heart problems, or stroke in adults with peripheral artery disease (a condition where the blood flow to the legs is reduced) and includes adults who have recently had a procedure to improve blood flow to the legs
How Rivaroxaban Works (Mechanism of Action)
Rivaroxaban prevents factor Xa from activating prothrombin to thrombin. Thrombin is a serine protease that activates fibrinogen to fibrin, which completes the clotting process. By preventing factor Xa from working, rivaroxaban thins the blood, making it take longer to clot.
Quality Standards and Manufacturing Excellence
Bio-Synth operates with an unwavering commitment to quality. Our manufacturing processes integrate
☐ WHO-GMP (Good Manufacturing Practices) compliance
☐ ISO 9000:2015 certification
☐ Adherence to ICH guidelines and pharmacopeia standards
Our facilities are equipped with cutting-edge technology and maintain strict adherence to GLP (Good Laboratory Practices), GDP (Good Documentation Practices), and cGMP (Current Good Manufacturing Practices). This results in consistent product quality, reinforcing Bio-Synth’s reputation for excellence.
Why Choose Bio-Synth for Rivaroxaban API
Bio-Synth adheres to stringent quality protocols to ensure that each batch of Rivaroxaban meets comprehensive global quality standards. Our robust quality control practices confirm the purity, potency, and safety of our products, ensuring reliable therapeutic results. Our 120kL WHO-GMP, ISO certified facility has a capacity to manufacture 1 MT of Rivaroxaban per month. Bio-synth manufacturers all intermediates of Rivaroxaban in-house, ensuring superior quality, price, and delivery schedules.
Advantages and Key Features of Rivaroxaban API
- Proven efficacy as a direct oral anticoagulant, with predictable anticoagulant effect and no routine coagulation monitoring required
- Has a rapid onset of action, with a Cmax of 2 to 4 hours.
- Has few drug interactions, no dietary interactions, is easy to use, is well tolerated and has superior safety in regard to bleeding events compared to Warfarin
- Has demonstrated equivalence, or in some cases, superiority to Warfarin in preventing stroke or systemic embolism.
Rivaroxaban API Suppliers and Manufacturers in India
As one of the leading manufacturers of Rivaroxaban in India, Bio-synth manufactures all intermediates in-house, enabling the highest quality, most competitive prices, and shortest lead times. With 81 years of manufacturing experience, our processes and systems are optimized to deliver the best quality product that matches your requirements
Rivaroxaban API price in India
The price of Rivaroxaban API provided by Bio-Synth depends on several factors, including order quantity, quality standards, and current market conditions. To get an accurate and customised quote, it’s best to contact Bio-Synth us directly, as we ensure competitive pricing and adherence to regulatory standards.
Frequently asked questions
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- Rivaroxaban is an anticoagulant that is used to treat blood clots in the veins of the legs (deep vein thrombosis or DVT) or lungs (pulmonary embolism or PE)
- Rivaroxaban can help prevent strokes in patients with nonvalvular atrial fibrillation (NVAF) by helping to prevent clots from forming
Bio-Synth stands out as a trusted Rivaroxaban manufacturer in India due to its strict adherence to global standards, such as WHO-GMP and ISO 9000:2015 certifications. We focus on high-quality, reliable production, offering competitive pricing and customizable solutions. Our robust quality control and consistent supply make Bio-Synth a dependable partner for pharmaceutical companies needing top-quality Rivaroxaban
Bio-Synth adheres to stringent quality protocols to ensure that each batch of Rivaroxaban meets comprehensive global quality standards. Our WHO-GMP and ISO 9000:2015 facility is equipped with cutting-edge technology and maintains strict adherence to GLP (Good Laboratory Practices), GDP (Good Documentation Practices), and cGMP (Current Good Manufacturing Practices) and is in the process of attaining EU-CEP and USFDA.
To place an order for Rivaroxaban, contact Bio-Synth through our customer service team or by filling out the contact form on our website. We provide comprehensive support to guide you through the order process and ensure timely delivery to meet your specific project needs.
Rivaroxaban prevents factor Xa from activating prothrombin to thrombin. Thrombin is a serine protease that activates fibrinogen to fibrin, which completes the clotting process. By preventing factor Xa from working, Rivaroxaban thins the blood, making it take longer to clot.
The following Number 366789-02-8 is the CAS number of Rivaroxaban API
Bio-synth is one of the leading manufacturers of Rivaroxaban API intermediates in India. With over 8 decades of experience manufacturing APIs and intermediates, Bio-synth offers high quality intermediates at competitive prices.
Bio-Synth operates with an unwavering commitment to quality. Our manufacturing processes integrate:
☐ WHO-GMP (Good Manufacturing Practices) compliance
☐ ISO 9000:2015 certification
☐ Adherence to ICH guidelines and pharmacopeia standards
Bio-Synth offers premium-quality Rivaroxaban API at competitive prices, tailored to meet your specific requirements. By handling all production stages internally, we maintain strict control over quality while optimizing pricing. For accurate pricing and to discuss your specific needs, we encourage you to reach out with your inquiry. Our team is dedicated to providing timely responses and ensuring your complete satisfaction.
Yes, Bio-Synth can supply Rivaroxaban API in bulk quantities. Please reach out to us via the enquiry form with your requirements and we will get back to you at the earliest.
