US Pharmacopeia

?? Nitrosamine impurities are in the news again, with the announcement of a recall of nearly 1.5 million bottles of an ADHD medication, atomoxetine capsules, due to the presence of N-nitroso atomoxetine at levels that exceed the U.S. FDA’s recommended acceptable intake limits. Nitrosamines are a type of impurity in pharmaceuticals that can potentially increase cancer risk with long-term exposure. Nitrosamines, including nitrosamine drug substance-related impurities (NDSRIs), can be formed in a variety of ways, from raw ingredients to manufacturing processes, including during packaging and storage. The pharmaceutical industry and regulators are working to limit the presence of nitrosamines in drugs to acceptable levels to ensure a safe supply of medicines and to help prevent the need for recalls, which take place when unacceptable levels of impurities are detected in products. The atomoxetine recall comes less than six months ahead of the August 1, 2025 FDA-requested deadline to finalize confirmatory testing for NDSRIs in drug products and submit required changes to drug applications. USP is helping the industry prepare for the deadline with resources and solutions including quality standards and reference materials, validated test methods, and the Nitrosamines Exchange, the online community platform where members actively engage in discussion and knowledge-sharing. Stay informed about the latest developments in controlling nitrosamine impurities in pharmaceuticals ??: https://ow.ly/2nbB50VheYm If you or someone you know is taking atomoxetine, consult your healthcare provider for guidance. ?? Share this post to help others stay informed. #USPScience #recall #atomoxetine #nitrosamines

USP was proud to co-host the 13th Meeting of the Regional Economic Communities (RECs) Medicines Regulatory Harmonisation in Africa alongside the African Union Development Agency - Health Programmes. The meeting discussed the integral role RECs play in supporting the operationalization of the African Medicines Agency (AMA) and assuring patients throughout Africa have access to safe, effective, and quality medical products. To safeguard access to safe, quality medicines across Africa, regulatory capacity must be strong at the national level, but also regionally. Together with the RECs, the AMRH Joint Secretariat, and other stakeholders, we made strides toward operationalizing a cohesive continental regulatory ecosystem to ensure, #qualitymedicines for all.

For over two decades, USP’s Dietary Supplement Verification Program has been helping to protect consumer health and assist manufacturers that want to demonstrate their commitment to quality. Only supplements that meet USP’s rigorous testing, review, and auditing criteria receive the #USPVerified Mark, which helps consumers navigate the crowded market to find products with quality they can trust. Interested in verifying your dietary supplements? Learn more about our Dietary Supplement Verification Program here: https://ow.ly/5WNT50UL8po

?? A closer look at the global API supply chain ?? Data from the USP Medicines Supply Map reveals major shifts in the global pharmaceutical supply chain over the past two decades. In 2023, ??India contributed 50% of active Active Pharmaceutical Ingredient (API) Drug Master Files filings ??China contributed 32%, showing steady growth ??Filings in the U.S. (4%) and EU (10%) have declined significantly With potentially new trade policies and tariffs, manufacturers must rethink offshore sourcing strategies. Without supply chain intelligence, businesses can face: ??Unexpected cost increases due to potential tariffs on key sourcing regions ??Over-reliance on limited suppliers, increasing the risk of disruptions How the USP Medicine Supply Map can help: ?NDC level insight on API suppliers’ site locations ?Volume share by country and different API suppliers Want to see the detailed report? Learn how USP's Medicine Supply Map can help you navigate supply chain complexities. Schedule a demo today ??: https://ow.ly/RiHS50VheQY #MedicinesSupplyMap

As ATCC celebrates our 100th year, we are proud to continue collaborating with US Pharmacopeia (USP) to offer the scientific community credible biological products to advance the quality and development of biologic medicines and therapies. USP’s SVP of Legal, Strategy & People, Amanda Cowley, JD, thoughtfully articulates the importance of partnerships like the one between ATCC and USP. Together, we are producing standards that instill confidence in the industry and its regulators while supporting products’ speed to market. We look forward to building on our successes with USP in 2025 and beyond! Learn more about our partnership: https://ow.ly/Gpze50VeaSG

Planning to attend #DCATWEEK March 17-20 in NYC? Connect with the USP team to explore solutions like our Medicine Supply Map, designed to forecast drug shortages and identify #supplychain risks, and our Ingredient Verification programs for excipients and APIs.

The deadline to apply for an Expert Volunteer role at USP has passed and applications are now closed. We are truly grateful for the incredible and historic response from applicants representing more than 120 countries around the world. The pool of candidates underscores the global commitment to advancing the quality of medicines, dietary supplements and food ingredients. Expert Committee Chairs will be confirmed in May, while Expert Committee Member selection will be finalized in June and formal invitations will be shared between June and July 2025. Follow our page to hear about future opportunities to contribute your expertise to USP. Recruitment for USP Expert Panels will begin in Summer 2025. More details will be available as the application period approaches. Thank you to everyone who applied! #USPExpertVolunteer #ProudToBeUSP

?? Naiffer Romero, Principal Scientist, USP is one of the five experts featured in a new five-part series 'Trends and Challenges in Nitrosamine Testing', published by The Analytical Scientist on the challenges posed by nitrosamine impurities in pharmaceuticals. Read Part One, 'Scoping the Problem,' in which Naiffer and the others set the stage for the series by discussing when nitrosamines first got their attention, the types, and risk levels. https://ow.ly/6msb50Vbaqr Share this post or leave a comment below ?? to receive alerts when future parts of the series go live. In Part Two, the experts will discuss the main analytical challenges associated with nitrosamines. Kevin E. Parker Jessica Hoskins Alan Thompson Jingyue Yang #USPScience #nitrosamines

? Do you have market visibility to understand how the pharmaceutical supply chain will respond? Did you know that 48% of global API Drug Master Files (DMFs) come from India, with the EU and China contributing 17% and 16%? Or that 11% of the most vulnerable medicines in the U.S. rely on manufacturing from Canada, China, and Mexico? The USP Medicines Supply Map (MSM) provides critical insights to help you navigate these interconnected supply chains and mitigate risks. Discover the origins of your medicines and APIs, and develop strategies to reduce disruptions. Contact us today to learn more about MSM and schedule a demo ??: https://ow.ly/6B8850Vb7Pr #MedicinesSupplyMap

Honoring Women in Science: Celebrating the Contributions of Black, Latina, Native American, and Indian Women This Women’s History Month let’s not just reflect—let’s act. Let’s build a future where gender equity in science is the norm, diverse voices drive innovation, and the next generation of women leaders have the opportunities they deserve. US Pharmacopeia we know that equity equals excellence—ensuring that diverse voices in science leads to better innovation, safer medicines, and stronger public health outcomes. Representation matters, and the achievements of women in STEM are proof that when all perspectives are included, we create stronger, smarter, and more effective solutions for all. Trailblazing Women Who Transformed Science ?? Dr. Marie Maynard Daly (Black American Biochemist) – Her research on hypertension laid the foundation for understanding cardiovascular health. ?? Dr. Helen Rodríguez-Trías (Latina Physician & Activist) – A public health advocate who revolutionized maternal and child health policies. ?? Dr. Susan La Flesche Picotte (Native American Physician) – The first Native American woman to earn a medical degree, dedicated to improving healthcare for Indigenous communities. ?? Dr. Anandibai Joshi (Indian Physician) – India’s first female doctor, who broke barriers and paved the way for women in medicine. ?? Dr. Asima Chatterjee (Indian Organic Chemist) – Her pioneering work in medicinal chemistry led to life-saving anti-epileptic and anti-malarial drugs. The Power of Representation in Science Women in STEM, particularly those from underrepresented backgrounds, have historically faced barriers to recognition and funding, yet their contributions have been essential to medical advancements that benefit everyone. Across the global USP and USP India we are committed to ensuring diverse expertise drives global health solutions. Through initiatives like the Expert Volunteer Recruitment (EVR) program, we seek global representation to shape standards that improve health outcomes worldwide. Deadline March 7, 2025 https://lnkd.in/eumte8Xv Call to Action: Elevate Women in Science ? Support women in STEM through mentorship, sponsorship, and leadership opportunities. ? Recognize and amplify the work of women in pharmaceuticals, healthcare, and regulatory science. ? Break barriers by challenging biases that keep women from leadership roles in science. At USP, we are committed to empowering women in science—because when women rise, we all benefit. #WomensHistoryMonth #WomenInSTEM #DiversityInScience #BlackWomenInSTEM #LatinaScientists #NativeWomenInScience #IndianWomenInSTEM #EquityEqualsExcellence