Hikal Limited shares fell more than 2% in morning trade on Friday after the company disclosed that it has received a warning letter from the United States Food and Drug Administration (US FDA) regarding its manufacturing facility in Jigani, Bengaluru. As of 9:18 AM, the shares were trading 0.87% lower at Rs 251.40.
The communication comes in the aftermath of an inspection carried out by the US FDA between February 3 and February 7, 2025. Hikal had earlier informed investors about the inspection and subsequent observations through its stock exchange filings on February 8 and May 23, 2025.
In its official statement, the company assured stakeholders that it is fully committed to working with the US FDA to address the issues raised in the letter. Hikal emphasized that quality, safety, and regulatory compliance remain its highest priorities. The company added that it is implementing corrective and preventive measures to resolve the concerns at the earliest.
Reaffirming its focus on global standards, Hikal highlighted that it continues to maintain current Good Manufacturing Practices (cGMP) across all its manufacturing sites. The company also reiterated its dedication to transparent disclosures and strengthening its compliance framework.
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