C3i Secures EMA Approval to Manufacture Cell Therapies for Europe

• C3i has received Good Manufacturing Practice (GMP) certification from the European Medicines Agency (EMA) to produce cell therapies for the European market.

• The company previously obtained a Drug Establishment License (DEL) to manufacture cell therapies for the Canadian market.

C3i has obtained regulatory approval from the European Medicines Agency (EMA) to manufacture cell therapies for the European market. The certification follows an inspection of the company’s Montreal facility, which confirmed compliance with Good Manufacturing Practice (GMP) standards.

This approval enables C3i, a Canadian contract development and manufacturing organization (CDMO) specializing in cell and gene therapies, to expand its reach beyond Canada. The company had previously secured a Drug Establishment License (DEL), allowing it to produce commercial cell therapies for patients in Canada.

With this latest milestone, C3i strengthens its position on the global biotechnology stage. The approval reflects the company’s regulatory expertise, high-quality standards, and the capabilities of its multidisciplinary team.

“As a Canadian CDMO, we’re proud to offer innovative solutions to the challenges of biomanufacturing and commercializing treatments that change lives,” said Yvan Côté, CEO of C3i. “Obtaining approvals from Health Canada and the EMA reaffirms our dedication to patient safety and the quality of therapeutic products.”