Safinamide methanesulfonate*

About us Polpharma Group Polpharma API API Manufacturing sites

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 mid-2023 with full completion scheduled for Q1 2024.

CDMO Competencies & Services Quality Environmental protection Customer experience

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.

Generics Core competencies Products

Our products are manufactured in accordance with the most stringent requirements of our customers and health authorities. 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. Our products can be additionally tested in compliance with the customer’s specifications.

Technologies Cryogenic High Potent Capabilities

Our products

Safinamide methanesulfonate*

CAS No.

202825-46-5

Reference product

Xadago/Zambon

Polymorphic form

Crystalline anhydrous form A1

Therapeutic Area

Nervous system

Status

commercial

EU DMF readiness

✓

US DMF readiness

034161

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 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.