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Hikal Secures Swissmedic GMP Certification for Bengaluru API Facility

The Swissmedic certification opens new opportunities for Hikal in Europe and other regulated markets.

Hikal’s Bengaluru API Facility Receives Swissmedic GMP Certification

Image: Hikal’s pharmaceuticals manufacturing facility in Jigani, Bengaluru

Hikal has announced that Swissmedic, the Swiss Agency for Therapeutic Products, has granted a Certificate of GMP Compliance of a Manufacturer to its active pharmaceutical ingredient (API) facility in Bengaluru.

The certificate confirms that the facility meets the Good Manufacturing Practice (GMP) requirements under the Mutual Recognition Agreement between the European Union and Switzerland.

The Swissmedic certification follows successful inspections of the Bengaluru facility by Brazil’s ANVISA and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).

Together, these regulatory recognitions strengthen the facility’s standing with leading global regulators and position Hikal to serve a wider customer base across regulated markets.

Hikal said the certifications also support its strategy to diversify the geographical footprint of its pharmaceutical business and build resilience against geopolitical and trade uncertainties.

Commenting on the development, Sameer Hiremath, chairman and managing director of 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 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,” he added.

Hikal is a life sciences partner to companies in the pharmaceutical, animal health, biotechnology, personal care and specialty chemicals industries. The company manufactures and supplies active ingredients, intermediates and biocides to the global life sciences industry.

Hikal operates five manufacturing facilities in India, located in Taloja and Mahad in Maharashtra, Panoli in Gujarat, and Jigani in Bengaluru. The company also has a Research and Technology Centre in Pune.

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