Mumbai, Dec 18 Shares of Sun Pharmaceutical Industries fell sharply on Thursday after the US drug regulator flagged one of the company’s manufacturing units in Gujarat.
The stock dropped nearly 3 per cent to Rs 1,738 per share, hitting a one-month low, after the US Food and Drug Administration classified Sun Pharma’s Baska facility in Gujarat as “official action indicated” (OAI) following an inspection.
An OAI classification means the regulator has found issues during inspection and may take regulatory or administrative action.
According to the USFDA, this status can lead to a delay or withholding of approvals for any pending product applications or supplements linked to the affected facility until the company addresses the observations related to manufacturing compliance.
The inspection at the Baska plant was carried out between September 8 and September 19, Sun Pharma said in a filing to stock exchanges.
At the closing bell, Sun Pharma shares were the biggest loser on the Sensex. The shares closed at Rs 1746, down by Rs 49.10 or 2.74 per cent.
The company clarified that it continues to manufacture and supply already approved products from the Baska facility to the US market.
Sun Pharma said it is working closely to resolve the issues and aims to achieve full compliance with USFDA norms.
“This is to inform that the US FDA conducted an inspection at the Company’s Baska facility from September 8 to September 19,” it said in its filing.
“The US FDA has subsequently determined that the inspection classification status of this facility is Official Action Indicated (OAI),” they added.
In terms of performance, Sun Pharma shares have fallen over 3.25 per cent in the last five trading sessions and are down around 0.73 per cent over the past one month.
However, the stock is still up nearly 6 per cent over the last six months. On a year-to-date basis, the shares have declined by more than 7.6 per cent.
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