Alimentary tract & metabolism
EU DMF readiness
US DMF readiness
Polpharma API characteristics:
- Mixture of anhydrous crystalline form A and B, same as originator
- Good control of impurity profile by handling 4 chemical steps in-house (2 isolated intermediates)
- PSD tailored to FDF needs
Linagliptin is an anti-diabetic agent and anti-hyperglycemic agent.
Linagliptin is indicated for the treatment of type 2 diabetes mellitus to improve glycemic control in adults.
It is formulated as tablets and film coated tablets for oral route of administration.
Mechanism of action:
Linagliptin acts as dipeptidyl peptidase-4 (DPP-4) inhibitor. The enzyme DPP-4 cleaves dipeptides from the N-terminal ends and interferes with the plasma level of bioactive peptides. Increase free fatty acid influx promotes liver inflammation. The drug candidate by inhibiting DPP-4 reduces the level of inflammatory cytokines such as TNF-alpha and interferon-gamma.
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.
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.