EU DMF readiness
US DMF readiness
Topiramate is a dioxolopyrans derivative acts as an anticonvulsant agent.
TPM is currently used as an additive treatment for adult patients with refractory partial and secondarily generalized seizure, and primary generalized tonic-clonic seizures. Topiramate can be used for adjunctive therapy in children aged 2 years and above, adolescents and adults with partial onset seizures with or without secondary generalization or primary generalized tonic-clonic seizures and for the treatment of seizures associated with Lennox-Gastaut syndrome. Topiramate is effecive in treating adults newly diagnosed epilepsy.
It is formulated as tablets for oral route of administration.
Mechanism of action:
Topiramate blocks the action potentials elicited repetitively by a sustained depolarization of the neurons in a time-dependent manner, suggesting a state-dependent sodium channel (voltage dependent sodium channel) blocking action. The frequency at which GABA-activated chloride channels (GABAA receptors) is increased by Topiramate and enhances the ability of GABA to induce a flux of chloride ions into neurons, suggesting that topiramate potentiates the activity of this inhibitory neurotransmitter.
Topiramate antagonizes the ability of kainate to activate the kainate/AMPA subtype of excitatory amino acid (glutamate) receptor, but had no apparent effect on the activity of N-methyl-D-aspartate (NMDA) at the NMDA receptor subtype and it also inhibits the carbonic anhydrase enzyme, particularly isozymes II and IV.
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.