Clemastine fumarate

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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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Clemastine fumarate

CAS No.

14976-57-9

Reference product

Polymorphic form

Therapeutic Area

Respiratory system

Status

commercial

Drug description:

Clemastine fumarate is the fumaric acid salt of clemastine. An antihistamine with antimuscarinic and moderate sedative properties, it is used for the symptomatic relief of allergic conditions such as rhinitis, urticaria, conjunctivitis and in pruritic (severe itching) skin conditions.

Mechanism of action:

Clemastine is a selective histamine H1 antagonist and binds to the histamine H1 receptor. This blocks the action of endogenous histamine, which subsequently leads to temporary relief of the negative symptoms brought on by histamine.

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