Piracetam

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.

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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.

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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

Piracetam

CAS No.

7491-74-9

Reference product

NOOTROPIL/UCB

Polymorphic form

Form II

Therapeutic Area

Nervous system

Status

commercial

EU DMF readiness

✓

CEP

✓

Other documentation

Brazilian DMF

💉 Available also
in injectable form

Drug description:

Piracetam is an antimyoclonic agent.
Piracetam is indicated in adult patients suffering from myoclonus of cortical origin, irrespective of etiology, and should be used in combination with other anti-myoclonic therapies.
It is formulated solution, syrup, film coated tablets for oral route of administration and injection, solution for intravenous route of administration.

Mechanism of action:

Piracetam is a positive allosteric modulator of the AMPA receptor.
It acts on ion channels or ion carriers leading to increased neuron excitability and has been found to increase blood flow glucose and oxygen consumption in parts of the brain which precedes cognitive improvement. Piracetam improves the function of the neurotransmitter acetylcholine via muscarinic cholinergic (ACh) receptors, which are implicated in memory processes. Furthermore, piracetam may have an effect on NMDA glutamate receptors, which are involved in learning and memory processes.

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).