Pimavanserin tartrate

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

Pimavanserin tartrate

CAS No.

706782-28-7

Reference product

NUPLAZID/ACADIA

Polymorphic form

Crystalline anhydrous form C

Therapeutic Area

Nervous system

Status

pipeline

EU DMF readiness

✓

US DMF readiness

033385

Polpharma API characteristics:

  • Crystalline Form C, same as in innovator’s tablets (physico-chemically most stable)
  • PSD tailored to FDF needs
  • Good control of Impurity profile by handling 4 chemical steps in-house (2 isolated intermediates)
  • Green chemistry – no phosgenation reactions

Drug description:

Pimavanserin tartrate acts as anti-psychotic agent.
Pimavanserin is indicated for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.
It is also under development for the treatment of hallucinations and delusions associated with dementia-related psychosis, psychosis in schizophrenia patients, Alzheimer’s disease agitation, Alzheimer’s disease psychosis (ADP), Dementia with Lewy bodies, Parkinson’s disease dementia, Vascular dementia, Frontotemporal dementia, as adjunctive treatment for the negative symptoms of Schizophrenia and Major Depressive Disorder.
It is formulated as film coated tablets for an oral route of administration.

Mechanism of action:

Pimavanserin selectively blocks the activity of the 5-HT2A receptor, a drug target that plays an important role in the treatment of various neuropsychiatric disorders. It works on the neurotransmitter serotonin, by binding with the 5-HT2A receptor.

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.