Hikal Limited, a life sciences partner to global pharmaceutical, crop protection, animal health and speciality chemical companies, secured Good Manufacturing Practice (GMP) certification from Swissmedic for its active pharmaceutical ingredient (API) manufacturing facility in Bengaluru. Swissmedic, the Swiss Agency for Therapeutic Products, has issued a Certificate of GMP Compliance of a Manufacturer to the facility. This certification confirms that the Bengaluru unit meets the GMP requirements under the Mutual Recognition Agreement between the European Union and Switzerland.
Strengthening Global Regulatory Compliance
The latest Swissmedic certification builds on successful inspections of Hikal’s Bengaluru facility by Brazil’s ANVISA and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). Together, these regulatory recognitions strengthen the facility’s compliance credentials and enhance Hikal’s ability to serve customers across major regulated pharmaceutical markets. Furthermore, they support the company’s strategy to expand the geographical reach of its pharmaceutical business while building resilience against geopolitical and international trade uncertainties.
Expanding Opportunities in Regulated Markets
Sameer Hiremath, Chairman and Managing Director of Hikal Limited, 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 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.” As per the press release, the Swissmedic GMP certification marks another milestone in Hikal’s efforts to strengthen its global pharmaceutical presence. It also reinforces the company’s commitment to maintaining high standards of quality, regulatory compliance and manufacturing excellence.
