Generic Orlistat contains the same active molecule as Xenical / Alli 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 Orlistat is available across 60 mg, 120 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 25 °C.
- 4
Test the supply chain
Trace batch numbers from the manufacturer through to your receiving dock.
Brand vs quality generic
| Factor | Xenical / Alli | Generic Orlistat |
|---|---|---|
| Active ingredient | Orlistat | Orlistat |
| Strengths | 60 mg, 120 mg | 60 mg, 120 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 Orlistat only from audited, licensed manufacturing partners, and supplies full documentation with every consignment for capsule presentations.
Orlistat at a glance
| Attribute | Detail |
|---|---|
| Drug class | gastric and pancreatic lipase inhibitor |
| Common brand | Xenical / Alli |
| Licensed use | weight management alongside a reduced-fat diet |
| Available strengths | 60 mg, 120 mg |
| Dosage form | capsule |
| Typical onset | effects on fat absorption from the first dose |
| Duration / dosing interval | acts locally in the gut per dose |
| Storage | below 25 °C |
