After the facility concludes the USFDA audit with 10 observations, the share price of Sun Pharma fal

After receiving 10 observations from the US Food and Drug Administration for its Halol factory, Sun Pharmaceutical Industries saw its share price drop by more than 4% in morning trading. The company announced today that the US health agency has inspected its Halol-based manufacturing facility in Gujarat and has issued a "Form 483" with ten observations. From April 26 to May 9, 2022, the US FDA inspected Sun Pharmaceutical Industries Limited's Halol facility (Gujarat, India) for compliance with good manufacturing practices (GMP).

According to the USFDA, Form 483 is given to a company's management following an inspection if the investigator found any circumstances that, in its opinion, may constitute violations of the Food, Drug, and Cosmetic (FD&C) Act and associated Acts.

The US FDA issued a Form-483 with 10 observations following the examination. Within 15 business days, the Company will submit its response to the observations to the US FDA.

"The Company is putting the observations response together, and it will be delivered to the US FDA in 15 working days," it says. The Company is dedicated to responding to these remarks as soon as possible, it was stated in a press statement.

Sun Pharmaceutical Industries' BSE quote at 12:43 hrs. was Rs 860.00, down Rs 25.40 or 2.87 percent. On April 29, 2022, and June 18, 2021, the share reached a 52-week high of Rs 966.90 and a 52-week low of Rs 652.75 respectively. After two days of straight gains, the stock has dropped, underperforming the sector by approximately 1.94 percent. On Monday, each share of Sun Pharma closed at $885.35 on the BSE.

The US FDA last inspected the Halol factory in March 2020, at which time it gave them an "official action suggested" status, meaning that additional regulatory measures may be taken against the plant if the mentioned observations are not addressed to the satisfaction of the drug regulator. Around 19 abbreviated new drug applications (ANDAs) and two new drug applications from this facility were pending as of 2020, which represented about 3 to 4% of their consolidated revenue. The entire series of circumstances suggests that Sun Pharma will probably need more time than expected to address these 10 observations.

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