Dapagliflozin

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.

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
 

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

Dapagliflozin

CAS No.

461432-26-8

Reference product

FORXIGA/AstraZeneca

Polymorphic form

Amorphous

Therapeutic Area

Alimentary tract & metabolism

Status

pipeline

EU DMF readiness

✓

US DMF readiness

030555

Other documentation

Korean DMF
Canadian DMF

Drug description:

Dapagliflozin belongs to anti-diabetic agents class.
It is indicated for the treatment of type 2 diabetes in adults aged 18 years and older with type 2 diabetes mellitus to improve glycemic control as mono-therapy and as add-on combination, as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
It is formulated as film-coated tablets and tablets for oral administration and intravenous administration.

Mechanism of action:

Dapagliflozin is a sodium glucose co-transporter 2 (SGLT2) inhibitor. The renal SGLT system plays a major role in overall glucose balance in the body. Dapagliflozin by an insulin independent mechanism leads to the excretion of excess glucose and associated calories in the urine, thereby lowering blood glucose levels.

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.