Strides’ Puducherry Plant Gets FDA Warning Letter
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.
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Appointing executives from Endo in key positions, Strides' CEO has set up a team to deliver growth, though the impact of ranitidine withdrawal and COVID-19 will defer a revenue target of $800m. Meanwhile, Stelis Biopharma signals a shift in focus from biologics development to CDMO opportunities and is poised for a stock exchange listing.
Strides' newly-appointed CEO, R Ananthanarayanan, sees no reason to change course as the firm's current strategy continues to yield positive results. The company posted a 29% increase in third-quarter revenues on the back of 62% growth in the US.
Strides Pharma Science, which has reported a strong second-quarter performance, said its reborn injectables business will “be full-blown” in several markets by December thanks to the expiry of a non-compete agreement with Mylan.