Hikal Limited has received a Certificate of GMP Compliance of a Manufacturer from Swissmedic, the Swiss Agency for Therapeutic Products, for its active pharmaceutical ingredient (API) manufacturing facility in Bengaluru. The certification confirms that the facility complies with Good Manufacturing Practice (GMP) requirements under the Mutual Recognition Agreement between the European Union and Switzerland. It adds to the facility’s regulatory approvals following inspections by Brazil’s National Health Surveillance Agency (ANVISA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).
The approvals strengthen the Bengaluru facility’s regulatory standing and support Hikal’s efforts to serve customers in Europe and other markets with stringent pharmaceutical manufacturing requirements. They also form part of the company’s strategy to expand the geographical reach of its pharmaceutical business and diversify its customer base.
Sameer Hiremath, Chairman and Managing Director of Hikal Limited, said the Swissmedic certification recognised the quality systems maintained at the Bengaluru facility. He said the approval would help the company pursue opportunities with customers in Europe and other regulated markets, while quality, compliance and manufacturing standards would remain central to its customer relationships.
Hikal supplies active ingredients, intermediates and biocides to companies in the pharmaceutical, animal health, biotechnology, personal care and speciality chemicals sectors. Its operations cover the life sciences value chain, with manufacturing facilities and research capabilities in India.
Established in 1988, Hikal operates five manufacturing facilities in India. These are located at Taloja and Mahad in Maharashtra, Panoli in Gujarat, and Jigani in Bengaluru. The company also operates a Research and Technology Centre in Pune. Its manufacturing sites have been inspected by regulatory authorities in several international markets. The company works with pharmaceutical, crop protection, animal health and speciality chemical businesses, supplying products for domestic and international markets.
The Swissmedic certification adds to the Bengaluru facility’s record of regulatory inspections and is expected to support Hikal’s engagement with customers seeking manufacturing partners that meet international GMP requirements. Hikal said it would continue to focus on manufacturing quality, regulatory compliance and customer requirements as it develops its pharmaceutical business and expands its presence in international markets.
