Valisure and Picket Pharmaceuticals Announce a Partnership for Independent Certification of Injectable Drugs

Picket Pharmaceuticals has engaged with Valisure to bring critically missing transparency and independent validation of chemical quality to the supply chain

NEW HAVEN, Conn. and NEW YORK, Dec. 6, 2024 /PRNewswire/ -- Valisure and Picket Pharmaceuticals have announced a strategic partnership to integrate Valisure's independent chemical analysis and certification program into Picket Pharmaceuticals' injectable drug product offerings. This collaboration aims to help address the primary market failure of generic drugs where a lack of transparency to quality combined with "race to the bottom" pricing has led to record levels of drug shortages in the United States.

Public health is increasingly threatened by unprecedented drug shortages where quality problems have been the top cause. According to FDA data for drug shortages with a known reason, 76% were caused by manufacturer quality issues in the years leading up to the COVID-19 pandemic, and recent data shows it continues to be a leading cause. Furthermore, there are approximately three drug recalls daily in the U.S., often due to dangerous impurities.

"Independent testing and quality transparency in the supply chain are vital to helping ensure the safety and efficacy of medications, and have been increasingly identified as key missing elements in the generic drug market that ultimately leads to quality problems and shortages," stated David Light, Co-Founder and President of Valisure. "We are excited to collaborate with Picket Pharmaceuticals on enhancing transparency and quality in the pharmaceutical supply chain at a time when it has never been more important."

Valisure and Picket Pharmaceuticals discovered their shared mission through their involvement in the End Drug Shortages Alliance (EDSA). At EDSA, the environment of urgency to not only understand the root problems leading to drug shortages, but to take substantive actions to prevent them and improve the pharmaceutical supply chain, led to the formation of an innovative partnership between Valisure and Picket Pharmaceuticals dedicated to creating industry-wide models for transparency and quality. Specifically with medicines in shortage, where purchasers experience pressure to quickly qualify new sources of supply, having a visible and meaningful additional layer of quality assurance is highly impactful for clinical teams, hospitals, pharmacists and the patients they serve.

"We've admired Valisure's success with independent quality assurance in solid oral medications and felt it was imperative to apply this critical capability to injectable drugs, where drug shortages and supply chain problems have been especially severe," said Joshua Kriger, Founder and CEO of Picket Pharmaceuticals. "I've been impressed by how easily the addition of independent testing fits into our existing quality manufacturing framework; it has made engaging with Valisure a no-brainer to transparently underscore to our customers Picket's commitment to the highest possible quality of products and processes."

Through this collaboration, Valisure's independent certification program will provide Picket Pharmaceuticals' customers with meaningful transparency about the chemical quality of their products. This initiative reinforces the commitment of both companies to address systemic challenges in the pharmaceutical supply chain and advocate for quality to be an integral part of sourcing and distributing medicines.

About Valisure:
Valisure is a pioneering technology company at the forefront of addressing a substantial gap in the healthcare supply chain through independent quality assurance. Our mission is to revolutionize the broken supply chain by providing a critically missing element: transparency to quality and independent certification through chemical analysis. At a time when transparency and reliability have never been more important, Valisure addresses a significant unmet need, reshaping the future of the healthcare supply chain. Explore collaboration opportunities with us to advance the quality assurance standard in healthcare at www.valisure.com.

About Picket Pharmaceuticals: 
Picket Pharmaceuticals is addressing the persistent issue of drug shortages and risks to the supply chain for essential medicines in the United States. Utilizing a variety of models, Picket supports the natural alignment of existing stakeholders, each with their unique operational and regulatory requirements. These stakeholders include active ingredient suppliers, manufacturers, purchasing pharmacies, hospitals, clinical care organizations, at-risk patient groups, and payers. Picket aims to enhance the value of in place stakeholder assets, deliver essential medications to where they are needed at the highest standard of quality, while saving the healthcare system unnecessary costs. Picket is working to fill the strategic need for a new, modern and robust advanced manufacturing infrastructure for essential medicines, firmly rooted in the United States.

SOURCE Valisure