In an exchange filng made during market hours today, Ipca Labs stated that the United States Food and Drug Administration (US FDA) conducted the inspection of the company's APIs manufacturing facility situated at Ratlam, Madhya Pradesh from 5th to 13th of June 2023.
At the conclusion of the inspection, the US FDA issued a Form 483 with 11 observations.
“The company 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 Labs said in a statement.
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 pharmaceutical 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.
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