Ticagrelor

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.

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
 

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

Ticagrelor

CAS No.

274693-27-5

Reference product

BRILINTA, BRILIQUE/AstraZeneca

Polymorphic form

Form II

Therapeutic Area

Blood & blood forming organs

Status

pipeline

EU DMF readiness

✓

US DMF readiness

028674

CEP

✓

Other documentation

Canadian DMF
Brazilian DMF

Drug description:

Ticagrelor is an antiplatelet agent.
Ticagrelor co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with acute coronary syndromes (ACS) or a history of myocardial infarction (MI) and a high risk of developing an atherothrombotic event.
It is formulated as tablets, film-coated tablets for oral route of administration.

Mechanism of action:

Ticagrelor is a platelet ADP P2Y12 receptor antagonist. It helps to prevent the formation of blood clots and reduces the occurrence of thrombotic events in acute coronary syndromes (ACS). ADP mediates platelet aggregation through its action on two G-protein-coupled receptor subtypes. The drug candidate is also acts by preventing adenosine from being cleared from the blood stream and by marginally increasing the levels of immune cell activity.

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.