Hikal faced a US FDA Jigani inspection, received an OAI classification, and pledged swift corrective actions and compliance.

• Inspection from Feb 3‑7, 2025, yielded six observations; the company is to respond within the regulatory timeframe promptly.
• Official Action Indicated status announced May 23, yet Hikal expects no disruption to product supply.
• Company reaffirms commitment to cGMP, quality, and continuous regulatory adherence across all facilities globally.