What is drug substance and drug product?

What is drug substance and drug product?

Drug substance is the active ingredient or Active pharmaceutical ingredient which is used to make the drug product, It is a pure material which exerts pharmacological action on the body. While drug product is the combination of drug substance or two or more more drug substance or excipients.

What are drug products?

More Definitions of Drug Product Drug Product means a finished dosage form (e.g., tablet, capsule, or solution), as defined in 21 C.F.R. § 314.3(b), that contains a drug substance, generally, but not necessarily, in association with one or more other ingredients.

What is the meaning of pharmaceutical product?

Photo credit: WHOPharmaceutical products – also known as medicines or drugs – are special preparations used in modern and traditional medicine. They are essential for the prevention and treatment of diseases, and protection of public health.

What is the difference between a drug and a drug product?

A drug substance, because of multiple factors (sensitivity, stability, etc.) is required to be mixed with other components before being released for use in the market. The drug substance together with the added ingredients (= excipients, see next chapter) is known as drug product.

What is the active ingredient of a drug?

According to 21 CFR 210.3(b)(7), an active ingredient is any component of a drug product intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of humans or other animals.

What are the types of pharmaceutical products?

What are the types of pharmaceutical products?

  • Oral drugs.
  • Parenteral Formulations.
  • Topical Medicines.
  • Modified release Formulations.
  • Novel Drug Formulations.
  • Oncological Formulations.

What are the types of pharmaceutical drugs?


  • Antipyretics: reducing fever (pyrexia/pyresis)
  • Analgesics: reducing pain (painkillers)
  • Antimalarial drugs: treating malaria.
  • Antibiotics: inhibiting germ growth.
  • Antiseptics: prevention of germ growth near burns, cuts and wounds.
  • Mood stabilizers: lithium and valpromide.
  • Hormone replacements: Premarin.