Sun Pharmaceutical Industries’ share price fell over four per cent in morning trade after the company received 10 observations for its Halol plant from the United States Food and Drug Administration. The company today said the US health regulator has issued a ‘Form 483’ with ten observations after inspecting its Halol-based manufacturing plant in Gujarat. The US FDA had conducted a Good Manufacturing Practices (GMP) inspection of Sun Pharmaceutical Industries Limited’s Halol facility (Gujarat, India) from April 26 to May 9, 2022.
As per USFDA, a Form 483 is issued to a firm’s management at the conclusion of an inspection when the investigator has observed any conditions that in its judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
At the conclusion of the inspection, the US FDA issued a Form-483, with 10 observations. The Company is preparing the response to the observations, which will be submitted to the US FDA within 15 business days.
“The Company is preparing the response to the observations, which will be submitted to the US FDA within 15 business days. The Company is committed to addressing these observations promptly,” the company said in a press release.
At 12:43 hrs Sun Pharmaceutical Industries was quoting at Rs 860.00, down Rs 25.40 or 2.87 per cent on the BSE. The share touched a 52-week high of Rs 966.90 and a 52-week low of Rs 652.75 on 29 April 2022 and 18 June 2021 respectively. The stock has fallen after two days of consecutive gains and has underperformed the sector by nearly 1.94 per cent. The Sun Pharma shares closed at 885.35 each on the BSE, on Monday.
Halol facility was last inspected by the US FDA in March 2020, wherein they were issued an ‘official action indicated’ status by the US FDA, which means that there could be more regulatory actions that could be undertaken for the plant in case the enlisted observations are not corrected as per the drug regulator’s satisfaction. As of 2020, this particular plant had around 19 abbreviated new drug applications (ANDAs), and two new drug applications pending from this facility, which was around 3 to 4 per cent of their consolidated revenue. The whole chain of events indicates that it is probably going to take Sun Pharma longer than anticipated to solve these 10 observations.
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