Sun Pharma shares drop for a second day after Dadra unit gets ‘OAI’ status from USFDA
Upstox
2 min read • Updated: April 15, 2024, 4:49 PM
Summary
An ‘OAI status’ by the USFDA means objectionable conditions or practices were found, and regulatory and/or administrative actions are recommended against the facility.
Shares of pharma major Sun Pharmaceutical Industries Ltd dropped more than 2% in trade on Monday, April 15, after declining 4% in the previous session, as the company’s Dadra unit came under the radar of the US health regulator.
In a press release dated April 11, Sun Pharma informed that the United States Food and Drug Administration (USFDA) conducted an inspection at the Dadra facility from December 4 to December 15, 2023.
The United States Food and Drug Administration (USFDA) subsequently determined the inspection classification status of this facility as ‘Official Action Indicated (OAI)’, Sun Pharma added.
According to the USFDA website, following an inspection, the agency evaluates the inspection findings to determine if the facility is in compliance with applicable laws and regulations and then classifies the inspection.
An ‘OAI status’ means objectionable conditions or practices were found, and regulatory and/or administrative actions are recommended against the facility.
In its filing to the stock exchanges, Sun Pharma said, “We will work with the regulator to achieve fully compliant status.”
Following the announcement, shares of Sun Pharma fell as much as 2.4% on Monday to hit an intraday low of ₹1,503.8 apiece on the NSE. However, the stock recovered some losses to close at positive at ₹1,540.1 apiece. On Friday, the stock had fallen 4% to close at ₹1,540 apiece.
Sun Pharma shares have gained over 53% in the last one year compared with an over 26% jump in the benchmark Nifty 50 index during the same period.
In December 2023, a USFDA report had mentioned that Sun Pharma was recalling products in the US market over manufacturing issues. The company had recalled 96,192 bottles of Liothyronine Sodium Tablets in the US that were used to treat an underactive thyroid, according to the enforcement report issued by the health regulator.
The affected product lot was produced at Sun Pharma’s Dadra-based facility. The company recalled the lot due to “failed impurities/degradation specifications'', the USFDA had said.