Sirio chewable gel added to the USP monograph with the new industry wide reference standards to take effect in December
Sirio Pharma (SIRIO) – the global nutraceutical contract development and manufacturing organization (CDMO) – announces its Ubidecarenone Chewable Gels have been added to the United States Pharmacopoeia (USP) monograph.
The addition to the monograph comes after three years of meticulous endeavor working alongside the USP to establish the required candidate documentary and reference standards to the benefit of global public health. These new standards will be the benchmark against which all future products are validated in terms of quality standards, minimum dose criteria, and formulation.
USP reference standards are used to assess nutraceutical specifications – including identity, potency, quality, and purity of dietary supplement and active pharmaceutical ingredients – and are widely used by regulatory bodies, industries, and independent third-party laboratories across over 150 countries.
Sirio conducted detailed studies on Ubidecarenone Chewable Gels Monograph , engaging in substantive technical exchanges with USP experts on best practices for quality criteria, and the standard received approval during USP Convention’s public review process, and Sirio has submit studies on other three Chewable Gels Monographs to USP Commission.
Significantly, this is the first time a CDMO headquartered in China has established a dietary supplement standard with the USP and subsequently been added to the USP monograph.
However, 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.
Youyou Zhao, Head of Global R&D Center, Sirio Pharma, commented: “We are delighted to be recognized in a certificate of appreciation from the USP for setting the nutra quality standard for chewable ubidecarenone gels, as well as for our contribution to global public health through advancing the safety of medicines and foods. This 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.”
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