ACTIVE PHARMACEUTICAL INGREDIENT (API)
A substance used in a finished pharmaceutical product, intended to furnish pharmacological activity or otherwise have direct effect in the diagnosis, cure, mitigation, treatment or prevention of a disease or to have direct effect in restoring, correcting or modifying psychological functions in human beings
HIGH-POTENCY API (HPAPI)
The compound is generally defined as highly potent. If it has an occasional exposure limit (OEL) of less than 10 µg/m3, a daily therapeutic dosage of less than 10 mg/day or if one mg/kg/day dose produces serious toxicity in laboratory animals.
The API Market – Large & Rapidly Growing Business
- Global sales of APIs are about $120 billion in 2016, including captive manufacturing and will grow to nearly $200 billion by 2021
- Global sales of HPAPIs are estimated at $10 billion in 2016
- While the API market is growing at a healthy rate of nearly 7% a year, HPAPIs are growing at a much faster rate in the low double digits