EU DMF readiness
Opipramol hydrochloride acts as an anxiolytic and antidepressant agent.
Opipram is indicated for the treatment of generalized anxiety disorder (GAD) and somatoform disturbances.
It is formulated as film-coated tablets for oral route of administration.
Mechanism of action:
Opipramol is a tricyclic antidepressive agent. Opipramol acts as a high affinity sigma receptor agonist, primarily of the σ1 subtype, but also of the σ2 subtype with lower affinity. Cyclic antidepressants block the absorption of the neurotransmitters serotonin and norepinephrine, making more of these chemicals available in the brain.
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.