Empagliflozin

• Safe process due to dedicated cryogenic installation (pilot plant and commercial scale)
• Exothermic controlled conditions
• Green Chemistry thanks to regeneration of solvents
• Capacity to fulfill high market demand
• Batch size up to 331 kg
• Tailor made PSD
• No risk of nitrosamines presence
• Zone 4b stability studies
• Wide portfolio for diabetes (Dapagliflozin, Linagliptin, Sitagliptin)

Status	Pipeline
Therapeutic cat.	Diabetics
Polymorphic form	Crystalline anhydrous
CAS No.	864070-44-0
EU DMF readiness
CHINESE??DMF
KOREAN??DMF
CANADIAN??DMF
US DMF readiness

Drug description

Empagliflozin is used together with diet and exercise to lower blood sugar levels in adults and children at least 10 years old with type 2 diabetes.Empagliflozin is also used to lower the risk of death from heart attack, stroke, or heart failure in adults with type 2 diabetes who also have heart disease.Empagliflozin is also used in adults to lower the risk of dying or needing to be in a hospital for heart failure when the heart cannot pump blood properly.Empagliflozin is not for treating type 1 diabetes.Empagliflozin may also be used for purposes not listed in this medication guide.

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Disclaimer: Products protected by patents (SPC) in Poland are developed solely for the purpose of Regulatory Submissions or R&D purposes intended to support Regulatory Submissions. These products are not offered for sale or made available in countries where such products are subject to patent (SPC) protection and where the offer for sale or any related activity constitutes patent infringement. It is within the buyer’s responsibility and liability to check the patent situation of the product in the import market(s). Based on exemption under art. 5(2) of the Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products Apixaban, Dapagliflozin (amorphous), Linagliptin, Rivaroxaban and Ticagrelor, which are protected by SPCs in Poland, can be manufactured and offered only for the purpose of export to non-EU countries, provided all requirements of the Regulationare met.