Hikal Limited Reports Revenue Decline in Q1 Amid Regulatory Challenges Aug 13, 2025
HIKAL Reports Q1 Net Loss of ₹224 Million Amid Revenue Decline Aug 07, 2025
More news about Hikal
30Jul 25
Hikal's Jigani Unit Secures GMP Certification from Japan's PMDA
Hikal Limited's Jigani Unit in Bangalore has received Good Manufacturing Practices (GMP) certification from Japan's Pharmaceutical and Medical Device Agency (PMDA) for Active Pharmaceutical Ingredients (APIs). The certification was granted after a four-day inspection from May 19th to 22nd. This achievement could open doors to the Japanese pharmaceutical market and enhance Hikal's global credibility. The company officially informed stock exchanges about this development on July 30th.
17Jun 25
Hikal's Jigani Unit Passes Brazilian Anvisa GMP Audit
Hikal Limited's Jigani facility successfully passed a Good Manufacturing Practice (GMP) audit conducted by Brazilian Anvisa, Brazil's health regulatory agency. This achievement signifies compliance with Brazilian regulatory standards and could potentially open new opportunities for Hikal in the Brazilian pharmaceutical market. The approval aligns with Hikal's strategy to strengthen its position in the global pharmaceutical supply chain and demonstrates its ability to meet international regulatory requirements.
Hikal Ltd successfully completed a Good Manufacturing Practice (GMP) audit by ANVISA, Brazil's regulatory authority, for its Jigani facility. This approval enhances Hikal's global credibility, opens opportunities for expansion in the Brazilian pharmaceutical market, and demonstrates the company's operational excellence. The ANVISA certification is expected to strengthen Hikal's position in the global pharmaceutical manufacturing landscape and may lead to increased collaborations with Brazilian and multinational pharmaceutical companies.
26May 25
Hikal's Jigani Facility Faces FDA Scrutiny with 'Official Action Indicated' Classification
Hikal Ltd. announced that its Jigani, Karnataka manufacturing facility has been classified as 'Official Action Indicated' (OAI) by the U.S. FDA following an inspection. This classification suggests significant issues were identified, potentially leading to regulatory actions. Hikal has committed to working closely with the FDA to resolve the issues and emphasized its ongoing efforts to enhance compliance measures. The OAI status could potentially impact new product approvals and existing product supply from this facility.
23May 25
Hikal's Jigani Facility Faces FDA Scrutiny with 'Official Action Indicated' Classification
Hikal Ltd's Jigani facility has been classified as 'Official Action Indicated' (OAI) following a U.S. FDA inspection, indicating significant objectionable conditions. The company has committed to addressing the FDA's concerns, working closely with the agency to resolve issues, and maintaining high-quality manufacturing standards. This classification may lead to increased regulatory scrutiny, require remediation efforts, and potentially impact new product approvals or existing product shipments from the facility.
HIKAL Limited, a specialty chemicals and pharmaceuticals manufacturer, reported impressive Q4 financial results. EBITDA increased by 30.16% to 1.23 billion rupees, with EBITDA margin expanding to 22.34%. Consolidated net profit surged by 47.65% to 502 million rupees. The company demonstrated significant year-over-year improvements across key financial metrics, indicating strong operational efficiency and market positioning.