In a regulatory filing, Ipca Laboratories said that the United States Food and Drug Administration (US FDA) had conducted the inspection of the its formulations manufacturing facility situated at SEZ Indore, Pithampur, Madhya Pradesh from 15 June 2023 to 23 June 2023.
At the conclusion of the inspection, the USFDA issued a Form 483 with 8 observations.
The drug maker stated that it will submit its comprehensive response on these observations to the US FDA within the stipulated time and shall work closely with the agency to resolve these issues at the earliest.
Ipca Laboratories is a pharmaceutical company with a strong thrust on exports which now account for 47% of company's income. IPCA is vertically integrated and produces finished dosage forms and active pharmaceutical ingredients.
The pharma company's consolidated net profit tumbled 41.24% to Rs 76.52 crore in Q4 FY23 as compared to Rs 130.23 crore reported in Q4 FY22. Revenue from operations increased 17% to Rs 1,511.63 crore during the quarter from Rs 1,289.10 crore recorded in the corresponding quarter last year.
Shares of Ipca Laboratories declined 0.37% to end at Rs 726.75 on Friday, 23 June 2023.
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