Generics

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.

Search for product

abcdefghijklmnoprstuvxyz

Back to products list

Linagliptin

Mix of form A & B

Therapeutic Area

Alimentary tract & metabolism

Status

Pipeline

EU DMF readiness

US DMF readiness

Other documentation

Chinese DMF
Korean DMF
Canadian DMF

CAS No.

668270-12-0

Reference Product

TRADJENTA/BOEHRINGER INGELHEIM

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.