JKB Financial Services Ltd.

As on : 22-Aug-2025

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22-Aug-2025 10:23

Hikal slides after receiving USFDA warning letter for Jigani Facility

The letter follows a regulatory inspection conducted at the site from 3rd to 7th February 2025. The company stated that it is working closely with the US FDA to resolve the issues raised and reiterated its commitment to upholding cGMP (current Good Manufacturing Practices) standards across all its manufacturing facilities. We uphold quality and compliance with utmost importance and are committed to addressing the concerns at the earliest, the company said in an official statement.

As per an earlier exchange filing dated 8 February 2025, the USFDA inspection at the Jigani unit concluded with six observations. Hikal had confirmed it would address each observation and submit its response within the stipulated timeframe.

In a subsequent filing dated 23 May 2025, the company informed that the inspection outcome had been classified as Official Action Indicated (OAI) by the US FDA. Despite the regulatory classification, Hikal emphasized that it does not anticipate any impact on business continuity or the supply of existing products from the Jigani facility.

The company added that it remains fully committed to maintaining the highest standards of quality and compliance at all its facilities and is actively working to enhance regulatory adherence on an ongoing basis.

Hikal is engaged in the business of pharmaceuticals, crop protection, and specialty chemicals.

The company reported consolidated net loss of Rs 22.40 crore in Q1 FY26 as against net profit of Rs 5.10 crore reported in Q1 FY25. Revenue from operations fell 8% YoY to Rs 371.30 crore in the quarter ended 30 June 2025.

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