Generic Dapagliflozin contains the same active molecule as Forxiga / Farxiga and must demonstrate bioequivalence to be approved. The difference between a good and a bad generic lies in the manufacturer, not the molecule.
Key takeaways
- Bioequivalence means the generic delivers the same exposure within accepted limits.
- GMP status and batch documentation are the real quality signals.
- Generic Dapagliflozin is available across 5 mg, 10 mg.
- A batch-specific certificate of analysis should always be available on request.
How to audit a manufacturer
- 1
Confirm GMP certification
Verify a current WHO-GMP or equivalent certificate and its scope covers this dosage form.
- 2
Review the CoA
Check assay, dissolution, related substances and microbiological limits against the specification.
- 3
Check stability data
Confirm the shelf life is supported for storage below 30 °C.
- 4
Test the supply chain
Trace batch numbers from the manufacturer through to your receiving dock.
Brand vs quality generic
| Factor | Forxiga / Farxiga | Generic Dapagliflozin |
|---|---|---|
| Active ingredient | Dapagliflozin | Dapagliflozin |
| Strengths | 5 mg, 10 mg | 5 mg, 10 mg |
| Regulatory basis | Full dossier | Bioequivalence to the reference product |
| Cost | Premium | Substantially lower landed cost |
| Documentation | Manufacturer pack | CoA, GMP certificate, stability data |
What we supply
ShiningRX sources generic Dapagliflozin only from audited, licensed manufacturing partners, and supplies full documentation with every consignment for film-coated tablet presentations.
Dapagliflozin at a glance
| Attribute | Detail |
|---|---|
| Drug class | SGLT2 inhibitor |
| Common brand | Forxiga / Farxiga |
| Licensed use | type 2 diabetes, heart failure and chronic kidney disease |
| Available strengths | 5 mg, 10 mg |
| Dosage form | film-coated tablet |
| Typical onset | glucosuria within 24 hours |
| Duration / dosing interval | 24-hour dosing |
| Storage | below 30 °C |