Dapagliflozin Tablets Suppliers & Bulk Manufacturers
Available Forms: Tablets
Available Strengths: 5 mg and 10 mg
Reference Brands: Forxiga(US & EU)
Category: Diabetes
Dapagliflozin Tablets is available in Tablets and strengths such as 5 mg and 10 mg. Sourced from GMP-certified and ISO-compliant manufacturers, this API meets global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical formulation and commercial manufacturing, Dapagliflozin Tablets is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.
| Technical Specifications & Supply Details | |
|---|---|
| Lead Time | 7 to 60 days (depending on batch size & schedule) |
| MOQ | As per manufacturer’s batch size |
| COA | Available with every batch |
| Regulatory Dossier / DMF | Available upon request |
| Export Documentation | FSC, COA, Manufacturing License, Product Permission |
| Standards | IP, BP, USP |
| Certifications | WHO-GMP, EU-GMP, USFDA (as applicable) |
Dapagliflozin Tablets can be exported to over 30 countries across Asia, Africa, Europe, and Latin America. Flexible packaging, competitive pricing, and a verified supplier network make Pharmatradz a trusted sourcing partner for pharmaceutical companies and contract manufacturers worldwide.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
Product Description: 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.
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