Certification Details
- Swissmedic granted a Certificate of GMP Compliance of a Manufacturer to Hikal's Bengaluru API facility
- The certification confirms the facility meets GMP requirements under the Mutual Recognition Agreement between the European Union and Switzerland
- Certification date: October 30, 2026 (as per the filing date)
Regulatory Context and Previous Approvals
The Bengaluru facility has previously received successful inspections from:
- Brazil's ANVISA (Agência Nacional de Vigilância Sanitária)
- Japan's PMDA (Pharmaceuticals and Medical Devices Agency)
Strategic Impact and Business Implications
The Swissmedic certification:
- Strengthens the facility's standing with global regulators
- Expands access to European and other regulated markets
- Advances the company's strategy to diversify the geographic footprint of its pharmaceutical business
- Builds resilience against geopolitical and trade uncertainties
- Opens new opportunities with customers in Europe and other regulated markets
Management Commentary
Mr. Sameer Hiremath, Chairman & Managing Director of Hikal Limited, stated: "The Swissmedic certification is a strong endorsement of the quality systems at our Bengaluru facility. It is an important step in expanding the global reach of our pharmaceutical business and opens new opportunities with customers in Europe and other regulated markets. Quality, compliance and manufacturing excellence remain the foundation of our long-term customer partnerships."
Company Background
Hikal Limited (BSE: 524735 | NSE: HIKAL) is a life sciences partner to global pharmaceutical, crop protection, animal health and specialty chemical companies. The company has:
- Five manufacturing facilities in India at Maharashtra (Taloja and Mahad), Gujarat (Panoli) and Bengaluru (Jigani)
- A world-class Research & Technology centre at Pune
- Responsible Care® certification and EcoVadis Gold Medal rating (top 5% globally for sustainability performance)