With the COVID-19 crisis, Valisure’s commitment to quality assurance in medications is more important than ever. As part of this mission, Valisure is offering analysis of samples of hydroxychloroquine free to healthcare systems, subject to availability. To submit a request, please click here.
Demand for hydroxychloroquine has skyrocketed and with it concerns over counterfeiting, supply from previously banned manufacturers, and significant reduction in FDA inspections. Valisure has no stance on the clinical efficacy of hydroxychloroquine but the facts are that this drug is in high demand, that health systems buying it are increasingly concerned about its quality, and that Valisure is in the position to help and willing to do so in as much as we’re able.
What’s Being Analyzed
As availability of resources allow, Valisure will run the following analytical tests on samples of hydroxychloroquine it receives from healthcare systems to analyze for authenticity and quality:
- Dosage – Verification of the amount of stated API being within USP specification.
- Inactive ingredients – Identification of the major inactive compounds comprising the tablet and comparing them to what is registered in the NDC. This has the potential to spot counterfeits.
- Dissolution – Analysis of how the tablet dissolves in physiologically relevant, stomach-like conditions.
- Carcinogens – Assessment for the presence of a variety of carcinogenic impurities, including nitrosamines like NDMA.
- Toxic elements – Testing for the presence of various toxic elements such as lead, mercury, arsenic and others.
How to Participate
If you belong to a healthcare system that is purchasing hydroxychloroquine because of the COVID-19 crisis and have concerns over the quality of the drugs you are using, please send us a message on our For Industry page.
A Message from the CEO
During the COVID-19 crisis, Valisure’s mission to help safeguard the safety and quality of the pharma supply chain is more important than ever. The potential for the market to be flooded with counterfeit, substandard, and tainted products is a serious concern. With routine FDA inspections being suspended, previously banned manufacturers being allowed to ship drugs to the U.S., and the dramatically increased demand for specific drugs like hydroxychloroquine, the need for greater vigilance over the pharma supply chain is crucial.
We’ve heard from multiple healthcare systems that they are particularly concerned about the safety and quality of the hydroxychloroquine that is being used to treat COVID-19 patients. Practitioners on the front lines of this crisis are under enough stress as it is and shouldn’t have to also worry about poor quality drug products.
We at Valisure hope that this free analytical service for healthcare systems will help identify any serious issues, if they exist, and offer some peace of mind to practitioners using hydroxychloroquine.
Please note there is no obligation to utilize or make referrals to any paid Valisure services in exchange for the analysis.