Windlas Biotech Dehradun plant gets no critical observation in EU inspection

Windlas Biotech Ltd on Thursday said it has concluded European Union good manufacturing practice inspection carried out by the National Institute of Pharmacy and Nutrition, Hungary, for its Plant-IV at Dehradun with zero critical observations.

In a regulatory filing, the company, which is a pharmaceutical formulations contract development and manufacturing organisation, said the inspection took place from April 11-13, 2022.

''Based on our preliminary discussion with the agency in the sum-up meeting, we estimate zero critical observations and deficiencies, including no observations related to Data Integrity issue,'' Windlas Biotech Managing Director Hitesh Windlass said.

The Inspection report will be issued by the agency within 30 days of completion of inspection, he added.

''The successful completion of this inspection will enable the company to explore new geographical expansion avenues and reinforce presence in the entire European market,'' Windlass said.