Sun Pharma clarifies on US FDA import alert on Halol plant

Sun Pharmaceutical Industries

Sun Pharmaceutical Industries Ltd on December 8 clarified further on US Food and Drug Administration (FDA) listing its Halol plant on import alert earlier today.

In a regulatory filing, Sun Pharma answered some questions on the development, especially with regard to its overall revenue.

Earlier today, the US FDA had listed the Halol facility in Gujarat under import alert with products manufactured at the unit now subject to refusal of admission in the US market. The development followed an inspection of the facility by the USFDA from April 26 to May 9, 2022.

Clarifying the effect on the revenue and the revision of future guidance of the company, Sun Pharma stated that US supplies from Halol contributed approximately 3 percent of consolidated revenues for the year ended March 31, 2022, including sales from exempted products. "We are not revising our revenue guidance for the current financial year," it said. It also added that there will be no impact on the specialty revenues either.

With the Halol facility under the scanner, the pharma company said that the backup facilities for key products manufactured in the plant will be "on a case-to-case basis."

"Site transfer of all products manufactured at Halol would be a complex and time-consuming process, considering that other manufacturing facilities may not have similar infrastructure. Hence, we would evaluate product transfers on a case-to-case basis," Sun Pharma said.

Further, answering the conditions required by the USFDA for the supply of 14 exempted products from the said facility, Sun Pharma said that the conditions for the supplies of 14 exempted products are "confidential," adding, "We are assessing the incremental costs to meet conditions for the supply of these products. However, we believe that the same will not be material."

On the impact of the import alert on revenues next year, the company clarified that its revenue guidance for next year, as and when shared, shall incorporate the same. It also stated that it had no information currently, whether the supplies to other markets get impacted due to the import alert.

Moreover, on how much time will the company require to get the Halol facility back into full compliance, Sun Pharma said, "We are working with the USFDA and will undertake all necessary steps to resolve these issues. At this point in time, we are unable to provide a timeline for resolution."

As per information available on BSE, Sun Pharma had clocked revenue of Rs 15,585.98 crore in 2021-22.

Sun Pharma had earlier today said it ''continues to cooperate with the USFDA and will undertake all necessary steps to resolve these issues and to ensure that the regulator is completely satisfied with the company's remedial action''.

Meanwhile, shares of Sun Pharma on Thursday (December 8) closed 3.57 percent lower at Rs 980.95 apiece on BSE post the US FDA import alert news.