Here's why top drugmaker Sun Pharma is trending lower today

Drugmaker Sun Pharmaceutical is facing some heat from the US Food and Drug Administration (FDA), according to a stock market disclosure by the company. 

The US FDA has listed Sun Pharma's facility in Gujarat’s Halol under an import alert, said the Indian drugmaker on Thursday, sending its shares down 3.3% at Rs 984.05 apiece in post-noon trade on the BSE.

Analysts expect there will be a 2-3% hit on Sun’s top-line and a 5-6% impact on EBITDA as a result of the FDA action, Busines Standard reported.

What has the company said about the FDA’s action?

“The Import Alert implies inter alia, that all future shipments of products manufactured at this facility are subject to refusal of admission to the US market until the facility becomes compliant with cGMP standards,” said the company in an exchange notification.

The USFDA has excluded 14 products from the import alert subject to certain conditions, said Sun, the eighth largest pharmaceutical company in the US generics market.

“For the year ended March 31, 2022, supplies to the US market from the Halol facility accounted for approximately 3 percent of the company’s consolidated revenues, including the 14 excluded products as mentioned above,” it said.

When did FDA inspections begin? What led up to the action?

The FDA inspected the facility from April 26 to May 9, 2022 and then issued a form with 10 observations. The facility was classified ‘Official Action Indicated (OAI)’ in March 2020, and was awaiting re-inspection from the US regulator. 

Due to travel restrictions for the pandemic, the re-inspection got delayed, and in May the FDA issued a form 483 with observations, which is an improvement over the OAI status.

Is there a history of inspections at the facility?

Yes. The Halol facility of Sun Pharma has been under the USFDA radar for the last few years. In December 2019, the USFDA inspected the Halol facility and issued Form 483 with eight observations. Following submission of the company’s response in January 2020, the USFDA classified the inspection status as Official Action Indicated.