Rivaroxaban API Manufacturers and Suppliers in India
Rivaroxaban is a direct oral anticoagulant that inhibits coagulation factor Xa without needing antithrombin III as a cofactor. Bio-Synth manufactures it as a bulk active pharmaceutical ingredient at Balanagar, Hyderabad, with certificates of analysis on file for USP and BP/Ph.Eur grades. The datasheet reads as follows.
Product Description
Product Description
Product: Rivaroxaban API
CAS Number: 366789-02-8
Chemical Name: (S)-5-chloro-N-{[2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]oxazolidin-5-yl]methyl}thiophene-2-carboxamide
Molecular Formula: C19H18ClN3O5S
Molecular Weight: 435.88 g/mol
Category: Factor Xa inhibitor, direct oral anticoagulant
Therapeutic Use: Prevention and treatment of venous and arterial thromboembolism
Physical Form: Powder
Colour: White or yellow
Solubility: Practically insoluble in water; freely soluble in dimethyl sulfoxide; practically insoluble in anhydrous ethanol and in heptanes
Storage: Store in an air-tight container below 30 degrees C
Packing: As per requirement
Synonyms: 5-chloro-N-(((5S)-2-oxo-3-(4-(3-oxomorpholin-4-yl)phenyl)-1,3-oxazolidin-5-yl)methyl)thiophene-2-carboxamide
The single most consequential property in that table is the first line of the solubility entry. Rivaroxaban is practically insoluble in water, so the dissolution behaviour of a tablet made from it is governed by the particle size and the solid form of the API rather than by anything the formulator does downstream. A batch that meets every chemical limit can still fail a dissolution profile if the crystal habit or the size distribution has drifted. Treat particle size as a release parameter you agree contractually, not as a nice-to-have.
Rivaroxaban API Specification
The published limits on this product are the tightest of any API in the Bio-Synth range.
Test | Limit |
Assay | 98.0% to 102.0% w/w, on the anhydrous substance |
Any unspecified impurity | Maximum 0.1% |
Total impurities | Maximum 0.3% |
Applications of Rivaroxaban API
A 0.3% ceiling on total impurities is demanding for a molecule assembled through an oxazolidinone ring closure and an amide coupling, and it deserves to sit in front of a buyer rather than be buried. Expressing assay on the anhydrous substance also tells you something: water is determined separately and subtracted, so the figure is not inflated by a dry batch.
Release testing against the USP or BP/Ph.Eur monograph covers description, identification by infrared absorption and by chromatographic retention, appearance of solution, related substances by HPLC, enantiomeric purity, water content by Karl Fischer, sulphated ash, residual solvents to ICH Q3C class limits, and assay. A certificate of analysis is raised for each batch.
Two controls sit outside the published set and both matter for this molecule. The particle size and purity in formulations article covers why these two parameters drive formulation outcomes.
Rivaroxaban API Manufacturers in India
Biochemical and Synthetic Products Private Limited has been manufacturing bulk drugs since 1943 and trades as Bio-Synth. The plant is at Plot No. 11/6/2029, Phase-2, SVCIE, Balanagar, Medchal-Malkajgiri district, Hyderabad, operating under Form 25 manufacturing licence 118/HD/AP/96/B/R, valid to 31 December 2026.
Rivaroxaban is built around a chiral 5-substituted oxazolidin-2-one, and the (S) configuration at that ring position is what the molecule works with. The route joins three pieces: the morpholinone-substituted aniline, the chiral oxazolidinone carrying an aminomethyl handle, and 5-chlorothiophene-2-carbonyl chloride for the final amide bond. Each junction contributes characteristic impurities, and the troublesome ones are the regioisomeric and des-chloro amides, which sit close enough to the product chromatographically that resolving them is an analytical problem before it is a purification problem.
With only 0.1% allowed for any single unidentified impurity, the purge strategy has to be designed into the synthesis rather than bolted on at the end. That is the honest answer to why rivaroxaban costs what it does, and why the questions worth putting to a supplier are analytical rather than industrial: which HPLC method resolves the known process impurities, is it validated for the ones your regulator will ask about, and will they send a representative related-substances chromatogram with the quotation. Bio-Synth’s chemistry and reaction capabilities set out what the site can run.
Rivaroxaban Intermediates Manufacturers and Suppliers in India
Bio-Synth manufactures pharmaceutical intermediates as a business in its own right rather than purely as inputs to its own APIs. The pharmaceutical intermediates page sets out what is offered. Buyers sourcing a rivaroxaban intermediate rather than the finished API should enquire directly, because the intermediates catalogue is maintained separately from the API range.
Rivaroxaban API Suppliers in India
Twenty-five kilogram fibre drums with an inner liner are the convention across the Indian rivaroxaban market, and the format most public listings quote against. Bio-Synth builds packing to order, so state what your warehouse and dispensary are set up for rather than assuming a default. Storage is in an air-tight container below 30 degrees C, and the shipping chain has to hold that.
Every commercial consignment carries a batch certificate of analysis and a safety data sheet. A certificate of pharmaceutical product can be obtained from the Telangana Drugs Control Administration where an importing regulator requires it.
Supplier choice on this molecule is wide, and the differentiator between quotations is almost never assay. It is the impurity profile, the particle size control, and whether the documentation matches the market you are filing into. Ask for those three in writing at quotation stage. The quality standards to verify in rivaroxaban API powder post works through the checklist.
Rivaroxaban API Price in India
Public prices for this molecule are all over the place, and it is worth knowing why before treating any of them as a benchmark. The Indian listings visible in search today run from a few thousand rupees per unit on catalogue and research-quantity entries, up to roughly eighteen thousand rupees per kilogram on a bulk marketplace listing, with an exporter quoting in dollars at a different order of magnitude again. Those figures describe different products in different quantities on different terms. None is a bulk contract price.
What actually determines the number Bio-Synth quotes:
- Impurity specification. Holding total impurities to 0.3% costs yield. A relaxed spec is cheaper and a tighter one is dearer, and the difference is real rather than notional on this molecule.
- Particle size requirement. Milling to a defined distribution adds a unit operation, a validation and a yield loss.
- Grade. USP and BP/Ph.Eur have different related-substance lists, and releasing against both is not the same cost as releasing against one.
- Volume and scheduling. Campaign-based production means a quantity that fits an existing run prices differently from one requiring a dedicated campaign.
Send the specification and the annual volume and you will get a number that means something.
Quality and Compliance
ISO 9001:2015. DNV Business Assurance UK Limited, UKAS accredited, certificate 156792-2014-AQ-IND-UKAS, held continuously since 20 August 2002. The certificate’s own wording covers “Development, manufacture and sale of active pharmaceutical ingredients (APIs), drug intermediates, biological products & liver injectable”. It certifies the quality management system at the site, not the product.
ICH Q7. The site manufactures in line with ICH Q7, the international GMP guideline for APIs, which governs change control, cleaning validation between campaigns and qualification of starting materials. The document Bio-Synth holds is a declaration signed by the company, not an external certificate.
WHO-GMP. Certificate L.Dis.No. 150458/TS/2024 from the Drugs Control Administration, Government of Telangana, runs to 5 June 2027. It was issued under the export certification scheme and covers only the products listed in the joint inspection report. That list names two products, and rivaroxaban is not one of them. The claim currently on this page that the API is WHO-GMP certified is being removed.
Bio-Synth holds no USFDA approval, no EU GMP certificate, no CEP, and has filed no drug master file for rivaroxaban. Several competitors ranking on this query do hold USDMF or EU GMP status and say so. That gap is a commercial fact worth stating rather than papering over, and buyers filing into the United States or the European Union should raise it before qualification begins. The quality systems page describes how batches are controlled and released.
How Rivaroxaban Works and Where It Is Used
Factor Xa converts prothrombin to thrombin, and thrombin converts fibrinogen to fibrin, the mesh that holds a clot together. Rivaroxaban binds factor Xa directly and selectively, so less thrombin is generated and clotting slows. It needs no antithrombin III cofactor, which is what separates the direct oral anticoagulants from heparin and its derivatives.
Finished products made with this API are prescribed for treatment and prevention of deep vein thrombosis and pulmonary embolism, stroke prevention in non-valvular atrial fibrillation, and thromboprophylaxis after hip or knee replacement. Approved indications differ by market, so formulators should work from their own product licence. The applications in anticoagulant drug development article covers the clinical picture.
Rivaroxaban API FAQs
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We believe that the heart of dialogue is listening.Please write in your queries and we will get back to you.
- C19H18ClN3O5S, molecular weight 435.88 g/mol, CAS 366789-02-8. Note the seventh character is a lowercase L for chlorine, not a capital i. The formula is currently mistyped as C19H18CIN3O5S on this page and that error should be corrected everywhere it appears.
Several Indian producers do, and public directories such as PharmaCompass and Pharmaoffer list them. Bio-Synth manufactures rivaroxaban at its Hyderabad site.
The originator brand is Xarelto. As an API it is also listed under its full IUPAC name and the synonym given in the product table above.
Certificates of analysis are on file for USP and BP/Ph.Eur grades.
It is the active ingredient in oral anticoagulant medicines used to treat and prevent blood clots, including deep vein thrombosis and pulmonary embolism, and to reduce stroke risk in non-valvular atrial fibrillation.
No. Neither a drug master file nor a CEP is recorded in Bio-Synth’s documentation for this product.
Yes, production is campaign-based against a purchase order.
Request a Quotation
Send the grade you need, the annual volume, the pack format and the destination market, together with your own specification if you have one. Particle size and impurity limits are the two things to state up front, because they are the two that change the answer.
You will receive a written quotation, the current specification, a representative impurity profile on request, and a straight account of which regulatory documents Bio-Synth holds for rivaroxaban and which it does not. Enquiries go through the contact page.
If you are consolidating suppliers across molecules, the wider API range is worth a look at the same time.