Carbamazepine

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We are a Poland-based CDMO and manufacturer of active pharmaceutical ingredients (APIs), that is proceeding with a $45-million manufacturing expansion of its main API plant in Starogard Gdanski to include HPAPI and cryogenic technologies and investments in a pilot plant and R&D capabilities. We expect to extend our operations starting from 2024 with full completion scheduled for Q3 2024.

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Polpharma API CDMO (Contract Development and Manufacturing Organization) supports emerging and large pharmaceutical customers in the development and commercialization of their small-molecule APIs clinical candidates thanks to +70 years of experience in process development, scale-up, and cGMP manufacturing of small molecule APIs in volumes ranging from kilos to tens of tons.

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We manufacture our products by following our customers' and health authorities' most stringent requirements. DMF documentation for all our products is prepared in accordance with the latest requirements of EDQM (CEP), ICH (EuDMF, CTD), and FDA (US DMF). Material and product testing is performed in line with the European and United States Pharmacopeias.

Technologies Cryogenic High Potent Capabilities
 

We are a Poland-based CDMO and manufacturer of active pharmaceutical ingredients (APIs) that is proceeding with a $35-million facility expansion of its main API plant in Starogard Gdanski to include HPAPI and cryogenic technologies and investments in a pilot plant and R&D capabilities. We expect to extend our operations starting from Q1 2024, with full completion scheduled for Q3 2024.

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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.

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