Hikal's Bengaluru API Facility Earns Swissmedic GMP Certificate, Opening European Markets

Hikal Ltd. announced on October 30, 2026, that its active pharmaceutical ingredient facility in Bengaluru has earned a Certificate of GMP Compliance from Swissmedic, the Swiss Agency for Therapeutic Products. ScanX reported the certification, which confirms the site meets Good Manufacturing Practice requirements under the Mutual Recognition Agreement between the European Union and Switzerland.

What the Swissmedic Certificate Covers

Hikal Ltd. is an Indian publicly-listed CDMO founded in 1988 that makes APIs, intermediates, crop protection chemicals and specialty chemicals for global pharmaceutical and agrochemical innovators across five manufacturing facilities and a Pune R&D centre. The Bengaluru site sits in Jigani, alongside plants in Maharashtra (Taloja and Mahad), Gujarat (Panoli) and the Pune research and technology centre.

The Swissmedic certificate follows inspections of the same Bengaluru facility by Brazil's ANVISA and Japan's PMDA. The company said the approval strengthens access to European and other regulated markets and supports geographic diversification of its pharmaceutical segment against geopolitical and trade uncertainties.

Sameer Hiremath, Chairman and Managing Director, said the certification is a strong endorsement of the quality systems at the Bengaluru facility. He said quality, compliance and manufacturing excellence remain foundational to long-term customer partnerships.

Hikal's Regulatory Record

According to akta.pro company records, Hikal received a USFDA warning letter for the Jigani manufacturing facility in August 2025, creating ongoing regulatory headwinds for the pharmaceuticals segment. The same records show full-year FY26 revenue of INR 1,713 crore, with Q4 FY26 revenue of Rs 519 crore. Hikal's funding records list one private equity round, a $50 million raise in November 2021 led by the International Finance Corporation.

Earlier Steps in Hikal's Expansion

Hikal began commercial production of personal care products at its Panoli, Gujarat facility on September 22, 2026, targeting second-generation UV filters for skincare, ScanX reported. The Hindu reported on September 21, 2026, that Hikal is incubating animal health and personal care businesses to diversify beyond pharma and crop protection, aiming to raise animal health revenue above ₹400 crore and personal care above ₹200 crore by FY30. On July 29, 2026, Manufacturing Today India reported that Hikal received an EcoVadis Gold Medal with a score of 84 out of 100, placing it among the top 5% of more than 175,000 companies assessed.

What Comes Next for the Bengaluru Site

Hikal has not stated a date for further regulatory action at the Bengaluru facility following the Swissmedic certificate.