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May 10, 2023

Hikal announces US FDA Audit with Zero Observations

Hikal Limited announced that the company's pharmaceutical manufacturing facility

Hikal Limited announced that the company's pharmaceutical manufacturing facility located at Panoli, Gujarat, was recently inspected by the U.S. Food and Drug Administration (US FDA) in compliance with their requirements, the company said through an exchange filing. The five-day detailed preapproval inspection of an API during the period May 8th - 12th, 2023 was concluded with 'Zero 483 observations’ from the US FDA Agency.

Sameer Hiremath, Managing Director commented, "As an organization we continue to maintain an excellent track record with global regulatory agencies. This latest audit re-emphasizes our commitment towards maintaining the best in class quality, compliance and regulatory standards across our manufacturing sites."

The Panoli facility was earlier audited twice by the US FDA and successfully approved for manufacturing advanced intermediates and key starting materials. Reflecting on the recent completion of US FDA inspection, Manoj Mehrotra, President – Pharmaceuticals added "Hikal is a leading manufacturer of APIs and Intermediates, and this approval is in line with our diversification strategy which gives us an additional API site to service our global customer base."

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