US Pharmacopeia

Attention dietary supplements manufacturers! We’re thrilled to share the latest benefit for participants in USP’s Dietary Supplement Verification Program—faster and seamless access to Amazon's market! Through Amazon’s Compliance Fast-Track Program, #USPVerified dietary supplements are automatically validated for compliance with Amazon’s policy requirements, saving you time, reducing complexity, and keeping your products selling. Learn more about the benefits of USP Verification for Amazon’s Compliance Fast-Track Program: https://lnkd.in/eYyB5PGw Sell on Amazon #DietarySupplements #Quality

Looking forward to Contract Pharma’s upcoming webinar featuring USP experts Dr. Ravi Kiran Kaja Ph.D and Dr. G. Prabhakar Reddy, as they discuss the latest in System Suitability Standards (SSS) and enhancements to General Chapters <1663> and <1664>. Don’t miss this chance to hear their insights on how evolving E&L standards are driving data reliability and safer medicines across the industry.

The Drug Shortage Task Force was formed to give a voice to the patients, providers, and communities who face the everyday harms of this health crisis. Alongside the National Association of Boards of Pharmacy and over 30 other groups, we urge policymakers to enact data-driven solutions to protect the availability of America's medicines. Catch up on our latest Congressional policy briefing below:

In continuing celebration of Hispanic Heritage Month and all year long, we’re honored to recognize the contributions, cultures and voices of USP’s Latina Scientists. Meet Maria Monagas! Dr. Monagas is a Principal Scientist in USP’s Department of Dietary Supplements and Herbal Medicines. She has a Ph.D in Food Science and Technology from the Autonomous University of Madrid (Spain) and an MSc in Industrial Fermentation Technology from Heriot-Watt University (Scotland, United Kingdom). Before joining USP in 2013, she was a tenured track Research Scientist at the Spanish Scientific Research Council (CSIC) in Madrid, Spain. At USP, Dr. Monagas is responsible for the development and review of USP monographs and General Chapters related to ingredients of botanical origin to be admitted into the USP-NF publication and the Dietary Supplements Compendium (DSC). She is also responsible for the USP Expert Panel on Botanical Dietary Supplements and Herbal Medicines for the Pan-American region. Dr. Monagas has more than 20 years of experience in the analysis and characterization of botanical ingredients used in the production of dietary supplements. She has contributed to more than 70 scientific publications, including original articles, book chapters, and industrial patents. 🌎Dr. Monagas is of Hispanic Caribbean heritage. 🔬 Dr. Monagas’s favorite quote: "God's mercies are new every morning” from Lamentations 3:22-23 🥼 Dr. Monagas’s motivations: “Knowing that my work contributes to something meaningful, to building part of the impactful USP legacy.”

The transition from the African Medicines Regulatory Harmonisation (AMRH) initiative to the African Medicines Agency (AMA) marks a critical step toward building harmonized regulatory frameworks across Africa. We were proud to take part in critical discussions this week at #SCOMRA2025 on strategies to strengthen regulatory systems and expand access to safe, quality medicines. We look forward to continued collaboration to accelerate regulatory harmonization and build resilient health systems. Learn more about USP’s work strengthening medicines regulatory systems: https://ow.ly/Bg4B50XrY5l

🎉 We’re proud to be named in BioSpace's 2026 Best Places to Work for the third year in a row! Being recognized among the top 20 large employers in life sciences is a testament to our incredible team and the culture we’ve built together — one rooted in innovation, collaboration, and growth – to help increase the availability of quality medicines, supplements and food ingredients worldwide. To our dedicated staff, thank you. Your passion, talent, and commitment make this recognition possible and make USP a truly special place to work. Learn more about how engaging our people makes a difference: https://ow.ly/wO9450Xr5Hx

Join speakers from USP, the Association for Accessible Medicines, and the FDA for a virtual discussion exploring how quality standards support regulators and manufacturers—and how the industry can actively participate in shaping future standards.     Happening December 11, 2025, topics include the FDA’s role in USP standards development, industry contributions, and how to engage in USP’s monograph development process.     Regulatory affairs professionals, FDA reviewers, quality managers, and pharmaceutical consultants working across brand-name and generic drug development won’t want to miss it.     Save the event below & register now: https://lnkd.in/e9C9zmVH

Bioequivalence (BE) studies are essential to ensuring the quality, safety, and efficacy of generic medicines and are critical enablers to expand access to affordable medical products and strengthen regional manufacturing in Africa. Join us for a dynamic session today at #SCOMRA2025! USP’s Leigh Verbois will lead a panel discussion with regulators, technical experts, and industry leaders to explore: ✅ The current landscape of BE capacity and regulatory requirements in Africa ✅ Ongoing continental efforts to align BE standards ✅ Opportunities for collaboration to close infrastructure and capacity gaps Learn more: https://ow.ly/hoEq50XmPGm

We were energized by the collaborative spirit and scientific rigor demonstrated at last week's GRx+Biosims conference. With more than 125 FDA staff engaging alongside industry partners, this year's event showcased what's possible when regulators and scientists unite around our shared mission: ensuring patient access to quality, affordable medicines. Key Highlights: • Scientific excellence: Sessions on nitrosamines, immunogenicity, and emerging threats like extractables and leachables underscored the industry's commitment to rigorous quality standards. • Transformative regulatory reform: FDA Commissioner Makary announced major biosimilar reforms—modernizing interchangeability designations and clinical efficacy study requirements to streamline development, provide common sense efficiencies for developers and speed up patient access to biosimilars across the U.S. • Global regulatory collaboration: Representatives from the FDA, Health Canada, EMA, and ANVISA aligned on streamlining requirements to advance regulatory harmonization, moving towards more flexible, science-based approaches. • Supply chain resilience: Critical discussions on drug shortages, global vulnerabilities, and market disruptions highlighted the challenges of maintaining a consistent supply of generic medicines. The convergence of regulatory modernization, global collaboration, and industry innovation creates unprecedented opportunities to advance patient access. Most importantly, this conference demonstrated that when standard-setting organizations, regulators, and industry maintain open dialogue focused on data and patient outcomes, meaningful progress happens. The dialogue doesn’t end here—join us as we continue the conversation. 📅 Upcoming Webinar: FDA/AAM/USP: Quality and Regulatory Predictability—Shaping USP Standards | December 11 | https://lnkd.in/e9C9zmVH #Biosimilars #FDA

USP is proud to sponsor the 7th Biennial Scientific Conference on Medical Products Regulation in Africa, #SCOMRA2025. We’ll be spotlighting our efforts to strengthen regulatory systems, build bioequivalence capacity, and expand access to quality medicines. Be sure to join us, in-person or online, for Parallel Session V, co-convened by Market Access Africa and US Pharmacopeia on building bioequivalence capacity in Africa. USP experts will also share perspectives on advancing access to quality medicines in Parallel Session XI and environmental sustainability in Parallel Session XIII. Learn more: https://ow.ly/KgzL50XmPyM