Polpharma API characteristics:
- Pure, stable, non-hygroscopic anhydrous crystalline form (same as in innovator tablets)
- Good control of impurity profile by handling 4 chemical steps in-house
- PSD tailored to FDF needs
- API from a producer experienced in Flozins including manufacturing and supply chain capabilities
- Technical support available on request
Empagliflozin is an anti-diabetic drug, belongs to the class of blood glucose lowering drugs.
It is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It is also indicated as an adjunct to diet, exercise and standard care therapy, to reduce the incidence of cardiovascular (CV) death in patients with type 2 diabetes and established CV disease who have inadequate glycemic control. Empaglifozin is also indicated to reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and cardiovascular disease.
It is formulated as coated tablets and film-coated tablets for oral route of administration.
Mechanism of action:
Empagliflozin is a sodium-dependent glucose transporter-2 inhibitor (SGLT-2 inhibitor). The drug candidate leads to reductions in hepatic glucose production and amelioration of glucotoxicity. The maintenance of glucose balance is the renal recovery of glucose from the glomerular filtrate mediated primarily by sodium glucose co-transporter 2 (SGLT2).