Sirio Pharma, a global nutraceutical CDMO, has had its ubidecarenone gummies added to the United States Pharmacopoeia (USP) monograph.
The addition of the nutraceutical comes after three years of collaboration with USP to establish the required documentary and reference standards.
The company will use these standards as a benchmark for all future products in terms of formulation, quality standards and minimum dosage.
USP references assess nutraceutical products on a number of aspects, including purity, quality, identity and potency — and are often used by regulatory bodies as a reference point.
Sirio has conducted studies on its ubidecarenone gummies, and has engaged in a number of exchanges with USP experts on how it can use best practises to ensure the quality of its product.
From this, it has receieved approval from the board during its public review process.
According to Sirio, this is the first time a Chinese-headquartered CDMO has successfully established a dietary supplement standard with the USP.
In total, Sirio has now been involved in the formulation of 35 global standards, demonstrating its long-standing commitment to furthering industry quality and transparency globally.
Head of Global R&D Centre, Sirio Pharma, Youyou Zhao, commented: “The addition of our ubidecarenone chewable gels to the USP monograph is a significant milestone in its own right, but also, an example of our company-wide ethos to push the boundaries of formulation science, quality and innovation. We believe in rigorous testing – for organoleptic properties, shelf-life and efficacy – and in driving evidence-based nutrition on every product we develop for our global customers.”