Product/Composition:- | Dapagliflozin Tablets |
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Strength:- | 5 mg and 10 mg |
Form:- | Tablets |
Reference Brands:- | Forxiga(US & EU) |
MOQ | As per the manufacturer batch size |
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Dapagliflozin is an SGLT2 inhibitor that reduces glucose reabsorption in the kidneys, promoting urinary glucose excretion. It improves glycemic control, supports weight loss, lowers blood pressure, and reduces the risk of heart failure and kidney disease progression. It offers once-daily oral dosing with cardiovascular and renal protective benefits.
Dapagliflozin, an SGLT2 inhibitor, is approved in both the USA and EU for treating type 2 diabetes, heart failure, and chronic kidney disease. In the USA, it is marketed as Farxiga®, approved via an NDA under 21 CFR, requiring robust safety labeling for risks like ketoacidosis and UTIs. In the EU, it is approved as Forxiga® through the centralized procedure by the EMA, with CTD-format submission, RMP, PSURs, and strict pharmacovigilance. Manufacturers must comply with GMP and post-marketing obligations. For regulatory consulting, global B2B sourcing, or dossier support, visit PharmaTradz.com.