Hikal’s Bengaluru API facility receives Swissmedic GMP certification
The certification follows inspections by Brazil’s ANVISA and Japan’s PMDA, supporting Hikal’s expansion across regulated pharma markets
Hikal has received a Certificate of GMP Compliance of a Manufacturer from Swissmedic, the Swiss Agency for Therapeutic Products, for its active pharmaceutical ingredient (API) facility in Bengaluru.
The certificate confirms that the facility meets the Good Manufacturing Practice (GMP) requirements of the Mutual Recognition Agreement between the European Union and Switzerland.
The Swissmedic certification follows inspections of the Bengaluru facility by Brazil’s ANVISA and Japan’s PMDA. These recognitions reinforce the facility’s standing with global regulators and position Hikal to serve a wider customer base across regulated markets.
The certifications also support the company’s strategy to diversify the geographic footprint of its pharmaceutical business and build resilience against geopolitical and trade uncertainties.
Commenting on the development, Sameer Hiremath, Chairman & Managing Director, Hikal, said, “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 pharma 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.”