Andexanet
Andexanet alfa is a recombinant modified factor Xa protein used as a reversal agent for certain direct oral anticoagulants, particularly apixaban and rivaroxaban, in patients experiencing life-threatening or uncontrolled bleeding, where approved and clinically indicated. It works by acting as a decoy for factor Xa inhibitors, binding these medicines and reducing their anticoagulant activity, thereby helping restore blood clotting. Andexanet alfa is administered intravenously in a hospital setting, with the dose and infusion regimen determined by the anticoagulant taken, its dose, and the time since the last administration. Important risks include thromboembolic events such as stroke, deep vein thrombosis, and pulmonary embolism, as well as infusion-related reactions and possible re-elevation of anticoagulant activity after treatment. Because reversing anticoagulation can increase the risk of blood clots, treatment requires specialist supervision, careful monitoring, and assessment of when anticoagulation should be restarted. Availability, approved indications, and recommendations may vary by jurisdiction.
Andexanet was historically used as a respiratory medicine for the symptomatic management of certain respiratory conditions. Its former uses included:
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The import of medicines into India is regulated by the Central Drugs Standard Control Organisation (CDSCO) under the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945. The regulatory requirements depend on whether the product is an active pharmaceutical ingredient (API), a finished formulation, or an unapproved medicine intended for an individual patient's treatment.
Primeera Healthcare Private Limited can provide import coordination and pharmaceutical documentation assistance for Andexanet, subject to confirmation of its current regulatory status and eligibility for import into India.
The export of Andexanet from India is subject to applicable requirements under the Drugs and Cosmetics Act, 1940, the Drugs and Cosmetics Rules, 1945, and relevant export, customs, and destination-country regulations. Documentation requirements depend on whether the product is an active pharmaceutical ingredient (API), a finished pharmaceutical formulation, or a medicine intended for a specific market. Export eligibility and destination-country requirements must be verified before shipment.
Primeera Healthcare Private Limited can provide pharmaceutical export documentation assistance, regulatory coordination, and shipping support for Andexanet, subject to confirmation of its export eligibility under applicable Indian regulations and the import requirements of the destination country.
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