An active pharmaceutical ingredient or drug substance used for pharmacological activity or diagnosis, treatment to affect the function of the body.

Drug Substance:

A drug substance or API used to cure or prevention of disease in the body. An API is manufactured intermediates used in the synthesis of substances.

APIs added some excipients are to dosage form like tablets, Capsules, Pellets, Injectables in formulation development, the are chosen that the active ingredient can reach the target in the body.

Examples:

Crocin tablet contains Paracetamol is an active pharmaceutical ingredient

Olafine or Movapine tablets contains Olanzapine is an API or Drug substance

Amilokind tablet contains Amlodipine is a drug substance

Drug Product:

The drug product is a drug substance and excipients, dosage form which are the ingredients of the tablet, Capsules, Orals or the liquid in the active agent is suspended or pharmaceutical inactive.

A finished dosage form like a tablet, capsule or oral that contains an active pharmaceutical ingredient, generally, in association with inactive ingredients.

Examples:

OfloxOZ tablets is a drug product dosage form that contains Titanium oxide color agent, Ofloxacin and Ornidazole are drug substances or active pharma ingredients.

Pharma excipients are substances that are contained in a pharma dosage form, no direct used therapy action for the manufacturing process, to protect, support for bioavailability.

Excipients:

Antiadherents, Binders, Coatings, Colours, Disintegrants, Flavours, and lubricants.

The difference between the API(DS)and Finished form(DP)is the drug substance is the active pharmaceutical ingredient that is used to make the drug product, a pure material which pharmacological action on the body.

The drug product is the combination of a drug substance or two or more drug substances or excipients. Tablets, capsules or injections are known as drug product while the active part which exerts action on the body which is present in tablets, capsules or injections are known as drug substances.

API Starting Material or Key raw material:

A Key raw material or API starting materials are used in the production of intermediates or an API

API starting materials are a significant structural fragment into the structure of the API. An API Starting Materials are a material purchased from one or more approved vendors under contract manufacturing units or commercial agreement suppliers or produced in-house.

Formulations:

The formulation is the process in which different from API processes, including the active pharma ingredient, are the combination of excipients to produce a drug product.