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Empagliflozin

CAS No.

864070-44-0

Reference product

JARDIANCE/BOEHRINGER INGELHEIM

Polymorphic form

Crystalline anhydrous

Therapeutic Area

Alimentary tract & metabolism

Status

pipeline

EU DMF readiness

US DMF readiness

033180

Other documentation

Chinese DMF
Korean DMF

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

Drug description:

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).

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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