Standards on the Frontlines: Responding to public health crises and strengthening supply chains
Vulnerabilities or disruptions to the global medicine supply chain (including dru… Read More
Vietnam pilot project spotlights the importance of international collaboration to control impurities and strengthen the medicines supply chain
A recently completed pilot projec… Read More
Part One: Industry examining FDA guidance on nitrosamines
Nitrosamine impurities in pharmaceutical products have been making major headlines recently, as this year has marked th… Read More
Pharmaceutical community eyeing FDA guidance on nitrosamines with great interest
Nitrosamines are naturally occurring chemical compounds that people are regularly exposed to a… Read More
Impurities in the medicines supply chain: Global cooperation essential to safeguarding patients
Continued global cooperation to strengthen supply chain resilience and assure med… Read More
Experiences strengthening quality assurance in the APEC region
Quality assurance is a wide-ranging concept encompassing all factors that collectively influence the quality attri… Read More
Insights from India: Q&A with USP nitrosamines expert
The issue of addressing potential nitrosamine impurities in medicines has been the focus at events taking place around… Read More
Standards support medicines supply chain resilience and the future of quality
It is not uncommon for people to sometimes take important things for granted, such as the quality o… Read More
The European Medicines Agency (EMA) has assessed the risk of nitrosamine formation or presence during the manufacture of human medicines and has provided guidance to marketing authorisation… Read More
Latest nitrosamines recall spotlighting need to control pharmaceutical impurities
The recent announcement of a recall of two lots of the hypertension medication Quinapril and H… Read More
Valsartan, losartan, irbesartan and other “-sartan” drugs are a class of medicines known as angiotensin II receptor blocker (ARBs) used to treat high blood pressure and heart fai… Read More
One more pharmaceutical organization is recalling a blood strain medicine that could improve the risk of most cancers if taken in substantial amounts.On Wednesday, Lupin Prescription drugs… Read More
The newest blood pressure medication remember arrives from Aurobindo Pharma, which yanked two a lot of Quinapril and Hydrochlorothiazide tablets for having way too a great deal of the nitros… Read More
Pfizer has issued voluntary recalls for several lots of its blood pressure medication Accuretic, and two generic versions of it, over concerns of higher than acceptable levels of a nitrosami… Read More
In this episode, Ayesha discussed Pfizer’s voluntary recall of several lots of its blood pressure medication Accuretic and two generic versions of it due to higher than acceptable leve… Read More
USP volunteering in the spotlight: Tackling critical public health needs
How does a 200-year-old standards-setting institution remain an essential part of ensuring access to tru… Read More
Great news: you have a safe, robust and scalable synthetic route to your API that will withstand the rigors of GMP.
But GMP involves more than synthetic chemistry…. so here’… Read More
World Standards Day: Recognizing How Standards Enable a Strong Medicines Supply Chain
Each year in October, we celebrate World Standards Day and the thousands of scientists and… Read More
Pfizer, the drug manufacturing giant, has recently expanded its prior recall of its popular anti-smoking medication, Chantix. The expanded recall is contemporaneous to the U.S. Food and Drug… Read More
In this episode, Ayesha discusses a set of recommendations for use of the new FDA-approved Alzheimer’s treatment Aduhelm (aducanumab) published by an expert panel, which was shared at… Read More
Special Interest Guidances/InformationDate PostedThe Use of Physiologically Based Pharmacokinetic Analyses — Biopharmaceutics Applications for Oral Drug Product Development, Manu… Read More
Metformin is used with a proper diet and exercise program and possibly with other medications to control high blood sugar. It is used in patients with type 2 diabetes. Controlling high bloo… Read More
It is also a common contaminant found in water and foods including cured and grilled meats, dairy products and vegetables, according to the FDA. The FDA is currently investigating whether… Read More
On September 13, the US Food and Drug Administration (FDA) stated that Ranitidine, an over the counter as well as prescribed medicine for acidity, had traces of N-nitrosodimethylamine (NDMA… Read More