What do you mean by drug products? (API, Heterocycle etc?) A pharmaceutical compound is generally a unique (patented) single molecule that has been tested for its toxicity and bioavailability.

A supplement is generally a multicomponent natural product with multiple activities.

15 years ago we synthesized natural molecules together with pharma compounds but the pharmaceutical industry did not want it ,they saw it as threat to their pure domain

Dear Sir,

Please let me know, Can we use the dietary supplement ingredients (RM) for the manufacturing of drug products and also claim on composition...?

For Exp- can we use the Bromelain material (US Grade) for manufacturing of drug products Tablets.

Using dietary supplement ingredients in drug manufacturing requires careful regulatory navigation.

Dietary supplements and drugs are distinctly regulated; supplements don't need FDA approval before marketing but must be safe and truthfully advertised. Drugs, however, require rigorous FDA approval demonstrating safety and efficacy through extensive testing.If an ingredient from supplements is used in a drug, it must undergo clinical trials to prove its effectiveness for the intended therapeutic use.

Labeling standards also differ significantly; drug labels need detailed medical information, whereas supplements have more general nutritional information.Misclassifying a product can lead to severe regulatory penalties. It’s crucial to consult regulatory experts or legal counsel to ensure compliance with all applicable laws when considering such development.

Yes, dietary supplement ingredients can be used in drugs, but they must meet strict drug regulations. This includes obtaining regulatory approval, meeting strict labeling requirements, and following pharmaceutical Good Manufacturing Practices (GMP). The product must be proven safe and effective as a drug, not just as a dietary supplement.