Indena Secures First-Ever European CEP Certification for CBD API

• Indena has received the European Pharmacopoeia Certificate of Eligibility (CEP) for its cannabidiol (CBD) extract, making it the first global API manufacturer to achieve this certification.

Indena has become the first active pharmaceutical ingredient (API) manufacturer worldwide to obtain a European Pharmacopoeia Certificate of Eligibility (CEP) for its cannabidiol (CBD) extract. Issued by the European Directorate for the Quality of Medicines (EDQM), the certification confirms that Indena’s CBD meets the stringent quality and safety specifications set by the European Pharmacopoeia.

The company, headquartered in Italy, produces its CBD extract for both clinical and commercial use. This latest achievement follows two key authorizations Indena secured in 2021—the Italian Ministry of Health’s approval for cannabinoid-based cannabis extract manufacturing and the Italian Medicines Agency (AIFA) authorization for pharmaceutical CBD production. Indena ensures full traceability and compliance by controlling its entire supply chain, from cultivation to final processing.

Indena’s CBD is derived from registered varieties of Cannabis sativa L., cultivated in Italy with a THC content of less than 0.2%. The company further refines the extract to ensure a residual THC level below 0.02%, exceeding the strict limits set by the U.S. FDA and DEA. These quality assurances enabled Indena to submit a Drug Master File (DMF) for its CBD product to the FDA.

Cecilia Nastro, Regulatory Affairs Department at Indena, commented on the achievement: “This CEP certification represents a significant step forward for Indena. The extensive analytical work undertaken by our team, who meticulously examined our API and processes to meet the demanding standards of this European certification, demonstrates our commitment to delivering high-quality, reliable pharmaceutical ingredients.”

The company processes its hemp biomass in a pharmaceutical-grade facility authorized by AIFA and inspected by global regulatory agencies, including the FDA, KFDA, and PMDA. All production adheres to Good Manufacturing Practices (GMP), aligning with Indena’s longstanding commitment to quality and regulatory excellence.