Available EU DMF/CEP
API Status
Therapeutic Category
Alimentary tract & metabolism
Anti-infectives for systemic use
Antipyretic, analgesic and anti-inflammatory
Antineoplastic & immunomodulating agents
Blood & blood forming organs
Cardiovascular system
Genito-urinary system & sex hormones
Injectable forms
Musculo-skeletal system
Nervous system
Opthalmological preparations
Respiratory system
Available US DMF
Available Japanese/Chinese DMF
Japanese DMF
Chinese DMF
Korean DMF




Reference product

Jardiance/boehringer ingelheim

Polymorphic form

Crystalline anhydrous

Therapeutic Area

Alimentary tract & metabolism



EU DMF readiness

US DMF readiness


Other documentation

Chinese DMF - under preparation

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).

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.