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Safinamide methanesulfonate

CAS No.

202825-46-5

Reference product

Xadago/Zambon

Polymorphic form

Crystalline anhydrous form A1

Therapeutic Area

Nervous system

Status

pipeline

EU DMF readiness

US DMF readiness

034161

Polpharma API characteristics:

  • Crystalline anhydrous modification A1, same as originator
  • Impurity profile control strategy based on optimum number of steps and materials selection

Drug description:

Safinamide is an alpha-aminoamide derivative acts as add-on therapy to dopamine agonists or levodopa.
Safinamide is indicated in the treatment of idiopathic Parkinson’s disease (PD) or for mid-to late-stage fluctuating patients as add-on therapy to a stable dose of Levodopa (L-dopa) alone or in combination with other PD medicinal products.
It is formulated as film-coated tablets for oral route of administration.

Mechanism of action:

Safinamide has a dual mechanism of action based on the enhancement of the dopaminergic function (through potent reversible inhibition of MAO-B and of dopamine uptake) and inhibition of excessive release of glutamate.

DISCLAIMER
The above product is presented solely for informational purposes and does not constitute an offer in any sense. Products with PIPELINE & EARLY DEVELOPMENT STATUS under patent (SPC) protection in Poland and/or other countries are not offered until expiration of the corresponding IP right.
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.

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