Apixaban

About us Polpharma Group Polpharma API API Manufacturing sites
 

We are a Poland-based CDMO and manufacturer of active pharmaceutical ingredients (APIs), that is proceeding with a $45-million manufacturing expansion of its main API plant in Starogard Gdanski to include HPAPI and cryogenic technologies and investments in a pilot plant and R&D capabilities. We expect to extend our operations starting from 2024 with full completion scheduled for Q3 2024.

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Polpharma API CDMO (Contract Development and Manufacturing Organization) supports emerging and large pharmaceutical customers in the development and commercialization of their small-molecule APIs clinical candidates thanks to +70 years of experience in process development, scale-up, and cGMP manufacturing of small molecule APIs in volumes ranging from kilos to tens of tons.

Generics Core competencies Products
 

We manufacture our products by following our customers' and health authorities' most stringent requirements. DMF documentation for all our products is prepared in accordance with the latest requirements of EDQM (CEP), ICH (EuDMF, CTD), and FDA (US DMF). Material and product testing is performed in line with the European and United States Pharmacopeias.

Technologies Cryogenic High Potent Capabilities
 

We are a Poland-based CDMO and manufacturer of active pharmaceutical ingredients (APIs) that is proceeding with a $35-million facility expansion of its main API plant in Starogard Gdanski to include HPAPI and cryogenic technologies and investments in a pilot plant and R&D capabilities. We expect to extend our operations starting from Q1 2024, with full completion scheduled for Q3 2024.

Our products

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.