The introduction of the Ph.Eur. Cannabidiol (CBD) monograph 3151, as part of Supplement 11.5, set a deadline of 1 July 2024 for manufacturers to bring their products into compliance with these new standards. Before this, CBD API manufacturers, including CB21 Pharma, adhered to the unofficial German Drug Codex document DAC/NRF 2020/2, C - 052.

CB21 Pharma has made significant efforts to ensure compliance in response to these changes. “Adapting to the Ph.Eur. 3151 monograph required us to expand the range of impurity testing for our cannabidiol isolates beyond what was specified in the German monograph. Despite the challenges in sourcing testing standards and performing the necessary assays, I’m pleased to confirm that as of March 11, 2024, our CBD API grade and CBD Compounding grade products are fully compliant with Ph.Eur. standards,” said Jan Storch, CEO of CB21 Pharma.

Boris Baňas, CB21 Pharma’s Head of Global API Sales, added, “Staying ahead of regulatory developments is a priority for us. This achievement not only demonstrates our commitment to meeting European and international manufacturing standards but also reinforces our dedication to providing high-quality, safe, and effective cannabinoid products to our global customers.”