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Linagliptin

CAS No.

668270-12-0

Reference product

TRADJENTA/BOEHRINGER INGELHEIM

Polymorphic form

Mix of form A & B

Therapeutic Area

Alimentary tract & metabolism

Status

pipeline

EU DMF readiness

US DMF readiness

029844

Other documentation

Chinese DMF
Korean DMF
Canadian DMF

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

Drug description:

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.

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.

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