Hikal FDA Inspection OAI Update

  Published 9 months ago

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.

You might like these

India-EU Near FTA Deal, Cyprus Boosts Ties

Bajaj Auto August 2025 Sales

Sai Silks Shares Jump 14.5%, Best Day Since Listing

HCLTech & AMD Partner for AI-Driven Digital Transformation

Vaibhav Global Q2 Profit Soars 71%

CaratLane Aims for Stronger Growth with Store Expansion and Lower-Carat Jewelry

PFC Q1 Profit Jumps 26%, Dividend Declared

News that matters the most ⚡