Our products

Carbamazepine

CAS No.

298-46-4

Reference product

TEGRETOL/NOVARTIS

Polymorphic form

Form III

Therapeutic Area

Nervous system

Status

commercial

EU DMF readiness

US DMF readiness

026266

CEP

Other documentation

Korean DMF

Drug description:

Carbamazepine is anti-epileptic agent.
It is used in the treatment of epilepsy – generalized tonic-clonic and partial seizures. Carbamazepine is not usually effective in absences (petit mal) and myoclonic seizures. Moreover, anecdotal evidence suggests that seizure exacerbation may occur in patients with atypical absences. It is indicated for the treatment of paroxysmal pain of trigeminal neuralgia. It is used in the prophylaxis of manic-depressive psychosis in patients unresponsive to lithium therapy.
It is formulated as tablets for oral route of administration.

Mechanism of action:

Carbamazepine stabilizes hyperexcited nerve membranes, inhibits repetitive neuronal discharges, and reduces synaptic propagation of excitatory impulses. It is conceivable that prevention of repetitive firing of sodium-dependent action potentials in depolarized neurons via use- and voltage-dependent blockade of sodium channels may be its main mechanism of action. Pain relief is believed to be associated with blockade of synaptic transmission in the trigeminal nucleus and seizure control with reduction of post-tetanic potentiation of synaptic transmission in the spinal cord. Carbamazepine greatly reduces or abolishes pain induced by stimulation of the infraorbital nerve and depresses thalamic potential and bulbar and polysynaptic reflexes, including the linguomandibular reflex. Whereas reduction of glutamate release and stabilization of neuronal membranes may account for the antiepileptic effects, the depressant effect on dopamine and noradrenaline turnover could be responsible for the anti-manic properties of carbamazepine.

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).
Polpharma’s strategic investment in HPAPI facility
We have launched an investment in a specialized facility
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.

LEARN MORE