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Sun Pharma Mohali facility under USFDA observation, pending drug approvals might get withheld

Sun Pharma Mohali facility under USFDA observation, pending drug approvals might get withheld

Sun Pharma Mohali facility under USFDA observation, pending drug approvals might get withheld
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By Ekta Batra   | Hormaz Fatakia  Nov 9, 2022 10:08:27 AM IST (Updated)

The US drug regulator inspected the Mohali facility between August 3-12 this year and issued a form-483 with six observations.

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Drugmaker Sun Pharmaceuticals' pending drug approvals from its facility in Punjab's Mohali might be withheld by US Food and Drug Authority (USFDA) till outstanding observations are resolved.
The drug firm informed the exchanges on Tuesday that the Mohali facility has been classified as Official Action Indicated (OAI). An OAI classification means that the USFDA may withhold approvals of any pending products until outstanding observations are resolved.
The USFDA can also initiate additional actions if needed under the consent decree. A consent decree was signed for the said plant in 2013.
The US drug regulator inspected the Mohali facility between August 3 and 12 this year and issued a form-483 to the company with six observations.
However, the company says that it continues to manufacture and distribute existing products for the US market, and this classification will not adversely impact current business from the facility.
Sun Pharma's Mohali unit is the erstwhile Ranbaxy plant for which the USFDA issued an import alert in 2013. The import alert on the plant was lifted in 2017. The plant manufactures oral solid dosages.
Among other regulatory issues for Sun Pharma, the company's Halol unit also continues to be classified as OAI. The regulator inspected the facility between April 26 and May 9 this year and issued 10 observations for the same.
In an interaction with CNBC-TV18 last week, after posting quarterly results, Sun Pharma Group CFO CS Muralidharan said that the company was working towards Halol plant remediation, but that would take some time.
The company has predicted higher single-digit to lower double-digit growth. The focus, according to Muralidharan, would be on efficiencies and maintaining the operating margin. He said spending on R&D could increase.
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