API manufacturer Indena has received European CEP certification for its pharmaceutical-grade, GMP-approved CBD extract.
The product is the first CBD extract to gain a certificate of eligibility from the European Pharmacopoeia (EP) — proving its compliance with the quality and safety specifications outlines by the regulator.
This certification makes Indena the first API manufacturer to achieve this milestone.
Indena's EP authorisation follows two previous approvals in 2021 — with the Italian Ministry of Health granting Indena permission to manufacture cannabinoid-based cannabis extracts, as well as the AIFA authorising the production of CBD for pharmaceutical use.
Indena's CBD extract is derived from both the flowers and aerial parts of Cannabis sativa L. through extraction and isolation processes.
To ensure that it is in compliance with Italian regulations — where the company's operations are based — Indena controls, certifies and traces the supply chain.
Cecilia Nastro, Regulatory Affairs Department, says: "This CEP certification represents a significant step forward for Indena. The analytical work undertaken by our team demonstrates our commitment to delivering high-quality, reliable pharmaceutical ingredients."
"This achievement positions us well to meet the growing global demand for rigorously certified CBD products,” she noted.
Cannabidiol (CBD) is an active pharmaceutical ingredient used in products approved for treating seizures associated with rare childhood epilepsy syndromes — including Lennox-Gastaut syndrome, Dravet syndrome, and tuberous sclerosis complex.
The ingredient is also currently under clinical development for other neurological disorders, schizophrenia and autoimmune diseases.