Excellence in compliance, quality, and patient safety
Altriva maintains the highest standards of regulatory compliance across all our operations. Our dedicated Regulatory Affairs team ensures that every product meets or exceeds the requirements of health authorities worldwide.
All Altriva manufacturing facilities are FDA-approved and regularly inspected. We maintain current Good Manufacturing Practices (cGMP) at every production site.
Our products are registered and approved in 30+ countries including US, Canada, EU member states, Japan, Australia, and key emerging markets.
Comprehensive quality management systems covering raw material sourcing through final product release. ISO 9001:2024 certified.
Robust drug safety monitoring systems ensure continuous surveillance of adverse events and proactive risk management throughout product lifecycle.
Altriva's regulatory strategy is built on proactive engagement with health authorities, rigorous scientific evaluation, and a culture of continuous improvement.
Altriva received FDA approval for AP-601, a novel oral anticoagulant for stroke prevention in patients with non-valvular atrial fibrillation.
European Commission granted marketing authorization for AltriStat, Altriva's next-generation statin therapy for hypercholesterolemia.
Altriva's Ohio manufacturing facility completed FDA pre-approval inspection with zero critical observations.
AltriBiotic-500 received World Health Organization prequalification, enabling procurement by UN agencies and global health organizations.
Patient safety is our highest priority. Healthcare professionals and patients are encouraged to report any adverse events or product quality concerns.
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