EU DMF readiness
Painkilling medication, primarily used to treat post-surgery moderate to severe, acute or chronic pain, also in the prevention of shivering.
Mechanism of action:
Effects in the brain and spinal cord to relieve pain via rather unique mechanisms. Firstly it increases the activity of serotonin, norepinephrine and dopamine, neurotransmitters involved in, among other things, pain signalling. Secondly it modulates sodium and calcium channels thereby inhibiting the release of glutamate, a key neurotransmitter involved in pain processing.
IPOCHEM API manufacturing site
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.