Apixaban Tablets Exporter and Supplier from India

Standard adult dosing for non-valvular AF stroke prevention is 5mg twice daily, per the ARISTOTLE trial regimen and NICE TA275. The 2.5mg twice daily dose is used where the patient meets two of three criteria: age 80 years or above, body weight 60kg or below, or serum creatinine 133 micromoles per litre (1.5 mg per dL) or above. The 2.5mg dose is also used in patients with creatinine clearance 15 to 29 mL per minute and for extended VTE secondary prevention beyond six months at the prescriber's discretion. We supply both 2.5mg and 5mg in matched pack formats to allow prescribers to switch between doses without changing brand or supplier.

Yes. The compound patent expired in the EU in October 2023 and generic apixaban is widely available in Germany, France, Spain and other EU mainland markets. The UK SPC expires in May 2026 and apixaban is entering the NHS Cat M tariff from mid 2026. M Care Exports holds active supply lanes into UK wholesalers and NHS hospital trusts with EU GMP origin product, QP release where required, FMD legacy serialisation and artwork prepared to MHRA Best Practice Guidance. Commercial Medicines Unit framework bids run quarterly and we can support tender response within five working days of the brief.

Apixaban formulations supplied by M Care Exports are validated under ICH Q1A(R2) at long term conditions of 30 degrees Celsius and 75 percent relative humidity, which corresponds to ICH zone IVa. Validated shelf life is 36 months in Al-Al blister and HDPE bottle pack with desiccant. Photostability is documented per ICH Q1B. The full stability summary including assay, dissolution, related substances, water content and appearance over the validation period is available in tabular and graphical form for SFDA, NUPCO, MOHAP and African regulator dossier filing within 48 hours of buyer brief.

Apixaban does not require routine coagulation monitoring, which is its defining procurement advantage over warfarin in LMIC tender markets without reliable INR laboratory infrastructure. Warfarin requires regular INR testing to maintain therapeutic range, and out of range INR is associated with stroke or major bleeding risk. Apixaban is dosed in two fixed strengths (5mg twice daily standard, 2.5mg twice daily for the dose reduction criteria) without titration. This removes the laboratory burden, simplifies the patient pathway and is increasingly preferred by African and Southeast Asian hospital procurement teams for atrial fibrillation stroke prevention. Warfarin remains first line for mechanical valves and triple positive antiphospholipid syndrome regardless of monitoring infrastructure.

Yes. Apixaban is on the NUPCO formulary as the preferred DOAC for atrial fibrillation in Saudi MoH facilities. M Care Exports submits dossiers under the GCC central registration pathway which accelerates multi country filing across Saudi Arabia, UAE, Kuwait, Bahrain, Oman and Qatar from a single technical submission. Documentation includes CPP with SFDA legalisation, Arabic English bilingual artwork, halal sourced lactose declaration where required, HOKA shipment documents and bilingual pharmacovigilance contact. Tender response within five working days is standard for active GCC supply lanes.

Each consignment carries a numbered documentation pack covering Certificate of Analysis per batch (assay, dissolution, related substances, water content, microbial limits, appearance), Certificate of Pharmaceutical Product in WHO format, manufacturer GMP certificate, finished product specification aligned to Ph Eur or USP monograph, ICH zone IVa stability summary, photostability data per ICH Q1B, packing list, commercial invoice, bill of lading or air waybill, and country specific legalisation including apostille, embassy attestation or Chamber of Commerce certification per importer requirement. Pharmacovigilance contact and ICSR reporting workflow are included with the technical pack.

Named patient supply into the UK is route specific and requires the hospital pharmacy to operate under MHRA unlicensed importer arrangements or a specials licensed wholesaler. We work with established UK specials suppliers to support named patient apixaban supply where the originator Eliquis is unavailable on the local hospital formulary or where a specific generic source is requested by the prescriber. From mid 2026 the UK SPC expiry opens generic apixaban for routine NHS Cat M framework supply, removing the need for the named patient pathway in most cases. Brief at the destination hospital pharmacy level and we will confirm the appropriate route.