Apixaban Tablet
| Product/Composition:- | Apixaban Tablet |
|---|---|
| Strength:- | 2.5mg, 5mg |
| Form:- | Tablet |
| Production Capacity:- | 10 Million Tablets/Month |
| Packaging:- | 10 X 10 Tablets / Box |
| Therapeutic use:- | Prevention of blood clots |
| Package Insert/Leaflet:- | Available upon request |
Introduction
Actiza Pharmaceutical is a WHO-GMP certified pharmaceutical exporter supplying Apixaban Tablets as a finished dosage formulation, not an API, in 2.5 mg and 5 mg film-coated presentations.
Apixaban is a direct factor Xa inhibitor used in stroke prevention in non-valvular atrial fibrillation and in the treatment and prevention of venous thromboembolism.
Every consignment is supported by a complete CTD dossier, also available in ACTD and eCTD format, with in-vivo bioequivalence data, CoPP, FSC and ICH Zone IVb stability.
Because apixaban remains patent-protected in a number of jurisdictions, we confirm freedom to operate in your specific market before quoting.
Strengths, Presentation & Specification
Apixaban Tablets 5 mg
The standard maintenance strength for stroke prevention in non-valvular atrial fibrillation and the higher-dose phases of venous thromboembolism treatment.
This is the volume strength in every market where the product is established, and it is the strength on which bioequivalence is normally demonstrated.
Apixaban Tablets 2.5 mg
Not simply a half dose. The 2.5 mg strength occupies distinct clinical positions dose-reduced atrial fibrillation therapy, extended prophylaxis after initial treatment, and post-orthopaedic-surgery thromboprophylaxis. Buyers typically tender both strengths together.
The Formulation Variables That Actually Matter
Apixaban is a non-ionisable molecule with low aqueous solubility and modest permeability.
Published biopharmaceutics modelling identifies API particle size distribution, granulation method and dissolution rate as critical quality attributes.
We specify and control particle size distribution explicitly.
Dissolution is validated across the physiological pH range, content uniformity is demonstrated at batch level, and moisture control is maintained across shelf life.
Regulatory, Dossier & IP Position
Dossier Availability
We provide dossiers in CTD (Common Technical Document), ACTD (ASEAN Common Technical Dossier), and eCTD formats.
Module 3 quality documentation includes API particle size specification, granulation process validation, dissolution method validation and moisture control strategy.
Stability data is provided under ICH Zone IVb conditions (30°C / 75% RH) for both real-time and accelerated testing.
Bioequivalence: A Conditional Biowaiver
European product-specific guidance describes apixaban as having incomplete absorption where available solubility data do not allow BCS classification.
If an applicant generates solubility data demonstrating high solubility, apixaban could be classified as BCS Class III with a biowaiver possible.
The practical gate is dissolution speed. Where an in-vivo study is required, guidance describes a single-dose study with intact tablets.
A crushed-tablet study may be required reflecting real clinical practice where tablets are crushed for nasogastric administration.
Drug Master File & Manufacturing
Drug Master File (DMF) reference for Apixaban API is available for cross-referencing.
Our WHO-GMP certified manufacturing facility is audit-ready, with Site Master File (SMF) available for regulatory submissions.
Granulation process parameters are controlled and documented as they affect dissolution behaviour and in-vivo performance.
Freedom to Operate
Apixaban is among the highest-revenue medicines with geographically uneven patent protection.
We do not accept orders where freedom to operate has not been established.
Clinical Indications & Therapeutic Information
Apixaban is a selective, reversible direct factor Xa inhibitor that inhibits both free and clot-bound factor Xa and prothrombinase activity.
Label indications include: reduction of stroke and systemic embolism risk in non-valvular atrial fibrillation; treatment of deep vein thrombosis and pulmonary embolism; reduction of recurrence risk following initial therapy; and prophylaxis of venous thromboembolism following hip or knee replacement surgery.
Boxed Warnings
The market is large and growing, driven by ageing populations and shift from vitamin K antagonists to direct oral anticoagulants.
Export Packaging & Supply Chain
Primary Packaging
Alu-Alu is the default recommendation for long-term therapy.
Apixaban therapy is often lifelong with repeated monthly opening, requiring moisture protection in Zone IVb markets.
Calendar packaging supports adherence given the boxed warning about discontinuation consequences.
Labelling & Customisation
Private label manufacturing available with your brand and artwork. Regulatory content remains unchanged.
Multi-lingual labelling available in English, French, Spanish, Portuguese, Arabic, and Russian.
Mandatory content includes both boxed warnings, do-not-stop-without-medical-advice instruction, interaction caution, storage statement and country-specific registration fields.
Logistics: Incoterms FOB, CIF, CFR, EXW as per buyer requirement.
No cold chain required; protect from moisture and sustained heat.
Supply planned against committed annual forecasts given the clinical importance of uninterrupted anticoagulation.
Why Source From Us?
Frequently Asked Questions
Q1. Can you supply Apixaban Tablets to my market?
Patent position is the first consideration, not registration. We obtain written confirmation of freedom to operate for your destination market before quoting and decline orders where that position has not been established.
Q2. Patent has expired in Europe has it expired everywhere?
No. European market exclusivity lapsed 19 May 2026. National positions within Europe can differ.
In the US, principal patents run to November 2026 while litigation settlements defer generic launch to no earlier than April 2028. Other regions are entirely separate.
Q3. Do you provide a dossier for Apixaban Tablets?
Yes, for markets that clear the eligibility screen.
We provide CTD, ACTD and eCTD dossiers covering both strengths with Module 3 quality documentation, particle size specification, granulation validation, dissolution validation, ICH Zone IVb stability and bioequivalence/biowaiver justification.
Q4. Is a bioequivalence study required or is biowaiver available?
Both routes exist. European guidance allows BCS Class III classification with biowaiver if the applicant demonstrates high solubility.
The practical gate is dissolution biowaiver may not be feasible where dissolution is under 85% in 15 minutes.
Q5. Why does API particle size matter so much?
Apixaban has low solubility and modest permeability, so dissolution rather than assay controls in-vivo performance.
Particle sizes below 120 µm support bioequivalence with reference formulations.
Q6. Do we need a crushed-tablet study?
Possibly. European guidance indicates a crushed-tablet study may be required, reflecting real clinical use where tablets are crushed for nasogastric administration.
Q7. Can you supply under our private label?
Yes, for eligible markets, with one limit: artwork must not adopt trade dress, colour scheme, tablet shape or embossing resembling the originator product.
Q8. What is MOQ and lead time?
MOQ varies by strength and pack configuration; both strengths are normally quoted together.
We do not quote until freedom to operate for your destination market is confirmed.
Tell us your target market and intended supply timeline.
Get in Touch
Enquiring about Apixaban Tablets? Tell us your destination market and intended supply timeline.
Our regulatory team will confirm the freedom-to-operate position and bioequivalence route your authority requires.
Where the position is clear, we will provide specifications, dossier format, pack options, lead time and pricing.