10 May , 2022 By : Kanchan Joshi
Sun Pharma 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. Sun Pharma shares were down 2% in noon trade.
“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 committed to addressing these observations promptly. The company remains committed to working closely with the US FDA and continues to enhance its GMP compliance on an ongoing basis," Sun Pharma said in a communication to exchanges.
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.
In the third quarter ended December 2021, Sun Pharma's consolidated sales from operations rose 11% year on year to Rs9814 crore. India formulation sales at Rs3,167 crore was up 15% over same quarter last year while US formulation sales at $397 million showed a growth of 6% over Q3 last year.
Its operating profit was at Rs2,557 crore, up by about 8% over Q3 last year, with EBITDA margin at 26.1%. Net profit for the quarter was at Rs. 2058 crore, up 11% YoY.
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