Generic Azithromycin contains the same active molecule as Zithromax 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 Azithromycin is available across 250 mg, 500 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 | Zithromax | Generic Azithromycin |
|---|---|---|
| Active ingredient | Azithromycin | Azithromycin |
| Strengths | 250 mg, 500 mg | 250 mg, 500 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 Azithromycin only from audited, licensed manufacturing partners, and supplies full documentation with every consignment for film-coated tablet presentations.
Azithromycin at a glance
| Attribute | Detail |
|---|---|
| Drug class | macrolide antibiotic |
| Common brand | Zithromax |
| Licensed use | respiratory, skin and selected STI infections |
| Available strengths | 250 mg, 500 mg |
| Dosage form | film-coated tablet |
| Typical onset | clinical response in 48–72 hours |
| Duration / dosing interval | long tissue half-life, once-daily short course |
| Storage | below 30 °C |
