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Apixaban

CAS No.

503612-47-3

Reference product

ELIQUIS/Bristol-Myers Squibb, Pfizer

Polymorphic form

Crystalline form N-1

Therapeutic Area

Blood & blood forming organs

Status

pipeline

EU DMF readiness

US DMF readiness

031166

Other documentation

Korean DMF
Brazilian DMF

Drug description:

Apixaban is a phenylpiperidine derivative, acts as antithrombotic or anticoagulant agent.
It is indicated to reduce the risk of stroke, systemic embolism in patients with non-valvular atrial fibrillation and for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery, treatment and prevention of the recurrence of venous thromboembolism (deep vein thrombosis and pulmonary thromboembolism).
It is formulated as tablets and film-coated tablets for oral route of administration.

Mechanism of action:

Apixaban is an anticoagulant direct factor Xa inhibitor. It is a reversible direct and selective inhibitor of factor Xa, which inhibits free and clot-bound factor Xa and prothrombinase activity, leading to indirect inhibition of platelet aggregation induced by thrombin which is responsible for activating fibrinogen and allowing clot formation. Apixaban plays an important role in inhibiting blood coagulation and preventing thrombosis.

DISCLAIMER
The above product is presented solely for informational purposes and does not constitute an offer in any sense. Products with PIPELINE & EARLY DEVELOPMENT STATUS under patent (SPC) protection in Poland and/or other countries are not offered until expiration of the corresponding IP right.
Polpharma’s strategic investment in HPAPI facility
We have launched an investment in a specialized facility
for the R&D and Production of highly active substances
with an OEL value of 10 ng/m3 (OEB 6).

The HP API investment includes separate process
laboratories (PDL), analytical laboratories (ADL)
with the possibility of performing Quality Control
analyses, and a GMP kilo-lab production line with
volume up to 1.5 kg with potential volume increase.

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