MUMBAI– Shares of Sun Pharmaceutical Industries fell sharply on Thursday after the U.S. Food and Drug Administration classified one of the company’s manufacturing facilities in Gujarat under “official action indicated” status following an inspection.
The stock dropped nearly 3 percent to Rs 1,738 per share, touching a one-month low, after the USFDA placed Sun Pharma’s Baska facility under the OAI category. The classification indicates that the regulator identified compliance issues during the inspection and may consider regulatory or administrative action.
According to the USFDA, an OAI status can result in delays or the withholding of approvals for pending product applications or supplements associated with the affected facility until the company satisfactorily addresses the observations.
Sun Pharma said the inspection at the Baska plant was conducted between September 8 and September 19, according to a filing with stock exchanges.
At the close of trading, Sun Pharma was the biggest decliner on the Sensex. The shares ended the session at Rs 1,746, down Rs 49.10, or 2.74 percent.
The company clarified that it continues to manufacture and supply already approved products from the Baska facility to the U.S. market and emphasized that corrective actions are underway.
“This is to inform that the US FDA conducted an inspection at the Company’s Baska facility from September 8 to September 19,” Sun Pharma said in its filing. “The US FDA has subsequently determined that the inspection classification status of this facility is Official Action Indicated (OAI).”
Sun Pharma added that it is working closely to address the regulator’s concerns and aims to achieve full compliance with USFDA requirements.
In terms of recent performance, the company’s shares have fallen more than 3.25 percent over the past five trading sessions and are down about 0.73 percent over the last month. Despite the recent decline, the stock remains up nearly 6 percent over the past six months, though it has fallen more than 7.6 percent on a year-to-date basis. (Source: IANS)
