Hikal Limited announced that its active pharmaceutical ingredient (API) facility in Bengaluru has received a Certificate of GMP Compliance from Swissmedic, the Swiss Agency for Therapeutic Products. This certification validates the facility’s adherence to Good Manufacturing Practice (GMP) requirements and strengthens its position in European and other regulated markets.
Hikal’s Bengaluru Facility Secures Swissmedic GMP Certification
Hikal Limited, a life sciences partner for global pharmaceutical, crop protection, animal health, and specialty chemical companies, has been granted a Certificate of GMP Compliance by Swissmedic, the Swiss Agency for Therapeutic Products. This certification applies to Hikal’s active pharmaceutical ingredient (API) facility located in Bengaluru.
Enhanced Global Standing and Market Access
The Certificate of GMP Compliance signifies that Hikal’s Bengaluru facility meets the stringent Good Manufacturing Practice (GMP) requirements stipulated by the Mutual Recognition Agreement between the European Union and Switzerland. This achievement builds upon previous successful inspections by Brazil’s ANVISA and Japan’s PMDA. The Swissmedic certification is expected to further enhance the site’s global regulatory standing and expand its access to European and other regulated markets.
Strategic Business Advancement
The company views these recognitions as crucial for reinforcing its standing with leading global regulators. This positions Hikal to serve a broader customer base across regulated markets and supports its strategic objective to diversify the geographic footprint of its pharmaceutical business, thereby building resilience against geopolitical and trade uncertainties.
Mr. Sameer Hiremath, Chairman & Managing Director of Hikal Limited, commented, “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.”
Source: BSE
