Empagliflozin

About us Polpharma Group Polpharma API API Manufacturing sites
 

We are a Poland-based CDMO and manufacturer of active pharmaceutical ingredients (APIs), that is proceeding with a $45-million manufacturing expansion of its main API plant in Starogard Gdanski to include HPAPI and cryogenic technologies and investments in a pilot plant and R&D capabilities. We expect to extend our operations starting from 2024 with full completion scheduled for Q3 2024.

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Polpharma API CDMO (Contract Development and Manufacturing Organization) supports emerging and large pharmaceutical customers in the development and commercialization of their small-molecule APIs clinical candidates thanks to +70 years of experience in process development, scale-up, and cGMP manufacturing of small molecule APIs in volumes ranging from kilos to tens of tons.

Generics Core competencies Products
 

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.

Technologies Cryogenic High Potent Capabilities
 

We are a Poland-based CDMO and manufacturer of active pharmaceutical ingredients (APIs) that is proceeding with a $35-million facility expansion of its main API plant in Starogard Gdanski to include HPAPI and cryogenic technologies and investments in a pilot plant and R&D capabilities. We expect to extend our operations starting from Q1 2024, with full completion scheduled for Q3 2024.

Our products

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.