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Shenzhen Haorui Pharmatech Co., Ltd.
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Dapagliflozin has been investigated either as monotherapy or as an adjunct treatment with insulin or other oral hypoglycemic agents. Dapagliflozin was originally approved by the FDA on Jan 08, 2014, to improve glycemic control in adults with type 2 diabetes in conjunction with diet and exercise. It was later approved to reduce the risk of kidney function decline, kidney failure, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease in April 2021. |
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Polpharma
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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 |
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| JAPANESE DMF |
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| KOREAN DMF |
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| CANADIAN DMF |
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| CADIFA |
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| US DMF readiness |
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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.
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. |
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Pharma Sources Insight January 2025
