Opipramol dihydrochloride

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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.

Our products

Opipramol dihydrochloride

CAS No.

909-39-7

Reference product

Insidon/NOVARTIS

Polymorphic form

Amorphous

Therapeutic Area

Nervous system

Status

commercial

EU DMF readiness

✓

Drug description:

Opipramol hydrochloride acts as an anxiolytic and antidepressant agent.
Opipram is indicated for the treatment of generalized anxiety disorder (GAD) and somatoform disturbances.
It is formulated as film-coated tablets for oral route of administration.

Mechanism of action:

Opipramol is a tricyclic antidepressive agent. Opipramol acts as a high affinity sigma receptor agonist, primarily of the σ1 subtype, but also of the σ2 subtype with lower affinity. Cyclic antidepressants block the absorption of the neurotransmitters serotonin and norepinephrine, making more of these chemicals available in the brain.

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