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 mid-2023 with full completion scheduled for Q1 2024.

CDMO Competencies & Services Quality Environmental protection Customer experience

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

Our products are manufactured in accordance with the most stringent requirements of our customers and health authorities. 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. Our products can be additionally tested in compliance with the customer’s specifications.

Technologies Cryogenic High Potent Capabilities

Our products

Apixaban

CAS No.

129722-12-9

Reference product

ELIQUIS/Bristol-Myers Squibb, Pfizer

Polymorphic form

Crystalline form N-1

Therapeutic Area

Blood & blood forming organs

Status

commercial

EU DMF readiness

✓

US DMF readiness

031166

Other documentation

Korean DMF
Brazilian DMF

Disclaimer
Products protected by valid patents are not offered for commercial sale in countries where the sale of such products constitutes patent infringement but are offered solely for uses reasonably related to the development and submission of information under a law regulating the manufacture, use or sale of drugs. It is within the buyer’s responsibility and liability to check the patent situation of the product in the imported market(s).

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.