EU DMF readiness
Aniracetam is a psychostimulant agent.
Aniracetam is indicated for disorders of attention and memory.
It is formulated as granule for suspension and as film coated tablet for oral route of administration.
Mechanism of action:
Aniracetam stimulates the function of some glutamate receptors in the CNS, and specifically the AMPA receptor and the metabotropic receptor. The AMPA receptor plays a pivotal role in the processes of learning and memory. Intervenes, in fact, in the maintenance phase of neuronal response amplified “Long term potentiation” (LTP) which is the basis of the learning process and leads, through gene activation, protein synthesis and the formation of new synapses. Aniracetam potentiates AMPA receptor function, prolongs the duration of the maintenance phase of the curve of the amplified action potential (LTP) and supports the processes of learning. Aniracetam lacks excitatory or inhibitory type effects on the CNS direct, does not affect the activity of the autonomic nervous system and cardiovascular system.
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).
for the R&D and Production of highly active substances
with an OEL value of 10 ng/m3 (OEB 6).
The HP API investment includes separate process
laboratories (PDL), analytical laboratories (ADL)
with the possibility of performing Quality Control
analyses, and a GMP kilo-lab production line with
volume up to 1.5 kg with potential volume increase.