API (Active Pharmaceutical Ingredient)
The biologically active component of a medicine, before it is formulated into a tablet, capsule or injection.
Definition
An Active Pharmaceutical Ingredient is the bulk chemical or biological substance responsible for a medicine's therapeutic effect. Formulators combine an API with excipients to produce the finished dosage form — a tablet, capsule, injection or cream. India exports roughly a quarter of its pharmaceutical value as bulk APIs, supplying formulators and manufacturers worldwide.
Why It Matters
Buyers sourcing APIs need a Certificate of Analysis and, for Tier 1 markets, a Drug Master File (DMF) or EDQM Certificate of Suitability (CEP) from the manufacturer — not the finished-formulation documentation used for tablets and capsules.