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Strides’ Puducherry Plant Gets FDA Warning Letter

 
• By Penelope MacRae

India’s Strides has received a warning letter from the US Food and Drug Administration over compliance issues at its Puducherry plant. However, the firm has told investors the regulatory action will not affect its forecast of 20% US sales growth for this financial year.

FDA_Truck
The FDA Has Warned Strides Over Its Puducherry Plant • Source: Shutterstock

Strides Pharma Science has been slapped with a warning letter from the US Food and Drug Administration over problems at its manufacturing plant in the western Indian city of Puducherry. But the firm, which has enjoyed a relatively strong regulatory compliance track record compared with some of its Indian pharmaceutical peers, said the notice will not affect its earnings guidance of 20% growth in US sales for the financial year to 31 March 2020. 

Strides founder and managing director Arun Kumar stated in May that the company was looking at 20% growth in year-on-year sales in fiscal 2020 from the US

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