By Malvika Gurung -- The pharmaceutical behemoth Sun Pharmaceutical Industries (NS: SUN ) has issued a set of clarifications in the form of questions and answers to the domestic stock exchanges, in relation to its facility in Halol, Gujarat listed under the ‘Import Alert’ clause by the US health regulator, US Food and Drug Administration (FDA) on Dec 8.
The drugmaker had informed that the 14 products exempted by the US FDA from the Halol facility under the Import Alert, contributed to almost 3% of the company’s consolidated revenues for the financial year ended March 31, 2022.
As per the latest details, the pharma major has decided to not revise its revenue guidance for the ongoing financial year even after the import alert at Halol, stating that there would not be any impact on its specialty revenues.
The company has added that the site transfer of all products manufactured at the facility in focus shall be time-consuming and a complex process, keeping in mind that other manufacturing facilities might not have a similar infrastructure.
Thus, on matters related to evaluating product transfers from the facility at Halol, Sun Pharma (NS: SUN ) approves going ahead with it on a case-to-case basis.
Regarding the revenue guidance for the upcoming financial year (FY24), the company has stated that it will incorporate the impact of the Import Alert in it as and when shared with the bourses.
The company’s Halol facility will remain under the Import Alert by the USFDA until it becomes compliant with the health regulator’s Current Good Manufacturing Practice (cGMP) standards.
“Sun Pharma remains committed to being cGMP compliant and in supplying high-quality products to its customers and patients globally,” its filing read.
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