Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent.
A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its regulatory submissions.
Firstline can source and supply RLD’s as required (specific batches & expiries) on an international scale.
The designation of a reference listed drug as the standard to which the generic version must be shown to be bioequivalent ensures that dosage, strength, safety, administration route, quality, performance, and intended use are therapeutically equivalent based on scientific evaluation and as such should have equal effect and no difference when substituted with the brand version.
Firstline is always looking to support the development of generic drugs to ensure global market access and maximise patient availability to treatment therapies worldwide by aiding manufacturers with the sourcing and supply of reference samples for research purposes.
Firstline Pharma is a dynamic, reliable pharmaceutical wholesale distributor company that imports and exports a wide range of healthcare products.
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