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FDA Import Alert At Sun’s Site: Here’s The Long And Short Of The Impact

 
• By Anju Ghangurde

US FDA import alert at Halol site comes as a setback for Sun Pharma, but analysts shrug off wider concerns for now given the low dependence on the facility for future growth. Investors are, however, also tracking the escalated compliance situation for the firm’s Mohali plant, inherited via the Ranbaxy deal.

Sun's facilities face compliance issues • Source: Shutterstock

Sun Pharmaceutical Industries Ltd.’s Halol facility continues to be stuck in a compliance rut in 2022, after the US Food and Drug Administration (FDA) placed the site under import alert, but analysts suggest that the escalation in regulatory action could have a low to marginal impact on the company’s overall growth story.

The Halol site in India has had a difficult compliance run over the past few years and last week the FDA said that the import alert included all drug products but “due to shortage concerns enforcement discretion currently being granted under this import alert and entries from the firm with certain matching drug/product code combination may be released”

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