The company said that its 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 five-day detailed pre-approval inspection of an API during the period from 8th to 12th May 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. 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.”

Hikal provides active ingredients, intermediates and R&D services to global pharmaceuticals, animal health, biotech, crop protection and specialty chemicals companies.

On a consolidated basis, net profit of Hikal declined 41.57% to Rs 26.41 crore on 6.28% rise in net sales to Rs 538.45 crore in Q3 December 2022 over Q3 December 2021.