Brexpiprazole

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

Brexpiprazole

CAS No.

913611-97-9

Reference product

REXULTI/OTSUKA

Polymorphic form

Form I

Therapeutic Area

Nervous system

Status

pipeline

EU DMF readiness

✓

US DMF readiness

032347

Polpharma API characteristics:

  • Anhydrous crystalline form, same as in innovator’s product
  • Control strategy set with limited genotoxic impurities needed to be tested in API
  • Product from manufacturer experienced in Aripiprazole chemistry
  • PSD tailored to FDF needs (up to D(0,9) < 10 μm)
  • Independent process
  • Technical support available on request – chosen preformulation data available

Drug description:

Brexpiprazole is an atypical antipsychotic and adjunctive antidepressant.
Brexpiprazole is indicated for the treatment of schizophrenia, as a maintenance treatment of schizophrenia in adults and as an adjunctive treatment of major depressive disorder (MDD).
It is formulated as tablets and film coated tablets for oral route of administration.

Mechanism of action:

Brexpiprazole is a serotonin-dopamine activity modulator (SDAM) that acts as a partial agonist at 5-HT1A and dopamine D2 receptors at similar potency, and an antagonist at 5-HT2A and noradrenaline alpha1B/2C receptors. Dopamine partial agonist distinguishing characteristic is their mechanism of action. These drugs are partial agonists at dopamine D2/D3 receptors and can act as dopaminergic stabilizers, performing as dopamine antagonists in conditions of dopamine hyperactivity and exhibiting dopamine agonist properties in states of hypoactivity.

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.