Crossject Achieves ISO Audit Success for ZEPIZURE®
Crossject is proud to announce the successful completion of another ISO 13485 audit at its manufacturing facilities in Dijon and Gray. This accomplishment highlights the company's commitment to maintaining high manufacturing standards, which are crucial for its epilepsy rescue therapy, ZEPIZURE®.
Preparation for U.S. Market
With the successful audit behind them, Crossject is now gearing up its supply chain operations in anticipation of commercializing ZEPIZURE® in the United States. The results of this ISO audit not only reaffirm the company's dedication to quality but also signify that they are one step closer to regulatory approval and market entry.
Quality Management System and Compliance
Crossject's ISO 13485 certification is maintained following an annual inspection carried out by the British Standards Institution (BSI). This certification illustrates the company’s compliance with international standards for manufacturing, particularly concerning its innovative ZENEO® needle-free auto-injector, which is integral to ZEPIZURE®.
The Significance of ISO Certification
“The ISO 13485 certification assures that our manufacturing sites and processes are in line with the highest international standards. The favorable findings reinforce Crossject’s rigorous manufacturing and quality protocols, which are essential for bringing our products to market. This lays a strong foundation as we scale up production for ZEPIZURE® and continue to enhance our manufacturing capabilities as needed,” said Patrick Alexandre, Chief Executive Officer of Crossject.
About Crossject
Crossject SA is an emerging specialty pharmaceuticals company specializing in medicines designed for emergency situations, leveraging its award-winning ZENEO® platform. The company is making significant strides in the regulatory development of ZEPIZURE®, which has received strong financial backing through a $60 million contract with the U.S. Biomedical Advanced Research and Development Authority (BARDA).
Innovative Solutions for Emergency Treatments
The ZENEO® platform is known for its ability to allow patients or untrained caregivers to administer a variety of emergency medications through intramuscular injection, either directly on the skin or through clothing. Apart from ZEPIZURE®, Crossject is developing solutions to address allergic reactions, adrenal insufficiencies, and various other emergency medical needs.
Contact Information for Inquiries
For more information about Crossject and its innovative products, please visit their website or reach out to the contacts listed below:
Investor Relations
Natasha Drapeau
Cohesion Bureau
+41 76 823 75 27
natasha.drapeau@cohesionbureau.com
Media Inquiries
Sophie Baumont
Cohesion Bureau
+33 6 27 74 74 49
sophie.baumont@cohesionbureau.com
Frequently Asked Questions
What is Crossject's main product?
Crossject primarily focuses on its epilepsy rescue therapy ZEPIZURE®, utilizing its ZENEO® needle-free auto-injector platform.
What certification did Crossject successfully maintain?
Crossject maintained its ISO 13485 certification, which demonstrates compliance with international quality management standards.
How does ZENEO® work?
ZENEO® allows easy and fast administration of emergency medications through intramuscular injections, which can be done on bare skin or through clothing.
What is the significance of the recent ISO audit for Crossject?
The recent successful ISO audit confirms Crossject's commitment to quality manufacturing, essential for supporting their supply chain and preparing for U.S. commercialization efforts.
Who can be contacted for more information about Crossject?
For inquiries, Natasha Drapeau handles investor relations, while media questions can be directed to Sophie Baumont.
