Crossject reports successful completion of European and U.S. audits for manufacturing of ZENEO® Midazolam for epileptic seizures
September 05 2023 - 12:30AM
Crossject reports successful completion of European and U.S. audits
for manufacturing of ZENEO® Midazolam for epileptic seizures
Press Release
Crossject reports
successful completion of European
and U.S. audits for
manufacturing of ZENEO®
Midazolam for
epileptic
seizures
ISO 13485 certification renewed for manufacturing
sites at Gray and Dijon
French Health Agency upgrades GMP certification
to commercial use
U.S. audit readiness of Crossject Dijon and Gray
manufacturing sites for a potential FDA audit
Dijon, France,
September 5, 2023 --
Crossject (ISIN: FR0011716265;
Euronext: ALCJ), a specialty pharma company
developing needle-free autoinjectors
for emergency situations, announces that its
manufacturing sites in Dijon and Gray (France) have passed an
annual ISO certification audit, expanded their scope of
certification by French Health Agency, and received positive
feedback after an audit by the Biomedical Advanced Research and
Development Authority (BARDA), part of the Administration for
Strategic Preparedness and Response within the U.S. Department of
Health and Human Services, on compliance of manufacturing ZENEO®
Midazolam for the U.S. market.
‘‘These positive reports from both sides of the Atlantic are an
important demonstration of Crossject’s stringent manufacturing and
quality systems standards. These are essential for Crossject to
ensure quality and bring our products to market in Europe and the
United States,” said Patrick Alexandre, CEO of
Crossject. “ZENEO® Midazolam will
provide a new, simple and reliable method of administering
emergency treatment of status epilepticus seizures, delivering
life-saving medicine rapidly and accurately. These certifications
will enable Crossject to continue to expand manufacturing capacity
as we aim to be a world leader in the self-administration of
emergency needle-free injectables.”
Preparatory audits have been carried out as part of the contract
with BARDA (#75A50122C00031) to evaluate compliance with cGMP
required by U.S. Food and Drug Administration (FDA) rules and to
assert readiness for a potential FDA audit. The audit found no
critical or major observations. Crossject Dijon and Gray sites met
all the requirements for manufacturing and control of its
auto-injector device under Quality Systems and CGMPs. The Company
previously signed a $60 million contract with the Biomedical
Advanced Research and Development Authority (BARDA) to procure
ZENEO® Midazolam upon receiving FDA clearance. According to the
contract terms, BARDA also has options to procure additional units
for up to $59 million. The total contract value if all options are
exercised is $155 million.
Furthermore, the British Standards Institution (BSI) Notified
Body conducted an annual audit of Crossject’s quality systems and
renewed its ISO 13485 certification, demonstrating compliance with
internationally recognized standards across the entire life cycle
of the ZENEO® needle-free injection system for its two France-based
manufacturing sites in Dijon and Gray.
In addition, the French National Agency for the Safety of
Medicines and Health (ANSM) has upgraded Crossject’s manufacturer’s
authorization to allow the transition from initial clinical to
commercial medicinal product use.
About Crossject
Crossject SA (Euronext:
ALCJ; www.crossject.com) is developing and will soon market a
portfolio of drugs for use in emergency situations (epilepsy,
overdose, allergic shock, severe migraine and asthma attack). With
its patented needle-free self-injection system, Crossject aims to
become the world leader in self-administered emergency medications.
The company has been listed on the Euronext Growth market in Paris
since 2014, and benefits from Bpifrance funding.
For further information, please contact:
Crossject Patrick Alexandre Chief Executive
Officerinfo@crossject.com |
Investors Natasha DrapeauCohesion Bureau+41 76 823
75 27natasha.drapeau@cohesionbureau.com |
MediaSophie BaumontCohesion Bureau+33 6 27 74 74
49sophie.baumont@cohesionbureau.com |
|
- Press release_Manufacturing_050923_EN
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