Hikal Ltd., a leading pharmaceutical and chemical manufacturing company, has received a warning letter from the United States Food and Drug Administration (US FDA) concerning its manufacturing facility in Jigani, Bengaluru. The notification follows the US FDA inspection conducted from February 3rd to February 7th, 2025, which was previously communicated to investors on 8th February 2025 and 23rd May 2025.
The company has stated that it is committed to working closely with the US FDA to address the issues raised and implement corrective actions promptly. Hikal emphasizes that quality and regulatory compliance remain a top priority, and it continues to uphold current Good Manufacturing Practices (cGMP) across all its manufacturing units.
This development is an important update for stakeholders and investors, reflecting Hikal’s transparent approach to regulatory compliance and its ongoing efforts to meet international quality standards.
Hikal assures that it is taking all necessary measures to resolve the FDA concerns swiftly, reinforcing its commitment to high-quality pharmaceutical manufacturing and global regulatory adherence.
