Clopamide

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 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.

Generics Core competencies Products
 

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

Clopamide

CAS No.

636-54-4

Reference product

Brinaldix/NOVARTIS

Polymorphic form

Polymorphic form

Therapeutic Area

Cardiovascular system

Status

commercial

EU DMF readiness

✓

Drug description:

Clopamide is a piperidine and sulfamoylbenzamide derivative acts as an antidiuretic agent.
Clopamide is indicated for treatment of hypertension.
It is formulated as tablet for oral route of administration.

Mechanism of action:

Clopamide acts at the proximal convoluted tubule site of the nephron where it inhibits the sodium-chloride cotransporter. Clopamide selectively binds at the chloride binding site of the sodium chloride cotransporter in the PCT cells on the luminal side and thus interferes with the reabsorption of NaCl and thus causing an equiosmolar excretion of water along with NaCl.

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).