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 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

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.

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

Pending

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.