Dapagliflozin

• Cryogenic process for improved safety and efficiency
• Green chemistry thanks to regeneration of solvents
• Wide portfolio for diabetes (Empagliflozin, Linagliptin, Sitagliptin)
• CADIFA pending

Status	Pipeline
Therapeutic cat.	Diabetics
Polymorphic form	Amorphous
CAS No.	461432-26-8
EU DMF readiness
JAPANESE DMF
KOREAN??DMF
CANADIAN??DMF
CADIFA
US DMF readiness

Drug description

Dapagliflozin is a prescription medication that is mainly used alongside diet and exercise to help treat type 2 diabetes, but it is also used in the treatment of heart failure. It was first approved by the US Food and Drug Administration (FDA) in 2014. Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor. This class of drug uses the kidneys to help control your glucose (blood sugar) levels. It works by increasing the amount of glucose removed from the body when you urinate. It also reduces the amount of effort your heart has to put in to pumping blood around your body.

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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.