Sun Pharma Addresses US FDA Import Notice For Halol Plant

Sun Pharmaceutical Industries on 8th Dec clarified its position further regarding US Food & Drug Administration (FDA) placing its Halol plant as an import alert earlier in the day.

In a regulatory document, Sun Pharma answered some questions regarding the development, particularly in relation to its revenue overall.

Today it was reported that earlier this morning, the US FDA has placed the Halol facility located in Gujarat under an import alert, with products produced at the facility now being considered for refusal of admission to the US market. 

The announcement came following an examination of the plant conducted by the USFDA between April 26 and May 9 2022.

To clarify the impact on revenue and revise the future guidance for Sun Pharma, Sun Pharma stated that US products from Halol made up about 3 percent of the consolidated revenue during the period that ended 31 March 2022. including sales of exempted products. 

“We will not be revising our revenue projections for the current fiscal period,” Sun Pharma said. It added that there is no impact on speciality revenues, either.

In addition to the Halol facility being under scanner, the pharmaceutical company has said that backup facilities for the key products produced in the facility will be “on the basis of a case-by-case.”

“Site transfers of the entire range of the products produced at Halol is a complicated and lengthy process, given how other facilities might not have the same infrastructure. Thus, we’d review the process on a case by case basis,” Sun Pharma said.

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In addition, in response to the requirements that are required by the USFDA to supply 14 products that are exempted from this location, Sun Pharma said that the requirements for the supply of exempted 14 products include “confidential,” adding, 

“We are evaluating the potential for incremental cost to satisfy the conditions to supply these items. However, we are of the opinion that this is not substantial.”

In relation to the impact from the alert to imports on revenue for the next fiscal year, the firm stated that its revenue forecast for the next year, if and when it is shared, will include the same. 

The company also said that it did not have any information as of yet, on whether supplies to other markets are affected because of an import warning.

In addition, what time it will take the company in order to bring it’s Halol facility back in complete compliance, Sun Pharma said, “We are in contact with the USFDA and will take the necessary steps to address these problems. At this time we cannot give a timeframe to resolve the issue.”

According to the information via BSE, Sun Pharma had reported a profit of Rs 15,585.98 crore between 2021 and 2022.

Sun Pharma had earlier today stated that it will continue to work in a positive manner with the US FDA and will take the necessary steps to address the issues and to ensure that the FDA is satisfied with Sun Pharma’s step”.

The Sun Pharma shares on Thursday (December 8) ended 3.57 percent lower, at Rs 980.95 each on BSE after news of the US FDA warning about imports announcement.