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.
Polpharma’s strategic investment in HPAPI facility
We have launched an investment in a specialized facility
for the R&D and Production of highly active substances
with an OEL value of 10 ng/m3 (OEB 6).

The HP API investment includes separate process
laboratories (PDL), analytical laboratories (ADL)
with the possibility of performing Quality Control
analyses, and a GMP kilo-lab production line with
volume up to 1.5 kg with potential volume increase.

LEARN MORE