The drug maker said that the US drug regulator has issued Form 483, with five observations after inspecting its subsidiary's formulations (oncology) manufacturing facility at Baddi, Himachal Pradesh.
In a regulatory filing, Aarti Drugs said that the United States Food and Drug Administration (US FDA) has inspected the formulations (oncology) manufacturing facility of its subsidiary, Pinnacle Life Science at Baddi, Himachal Pradesh from 16 April 2024 to 22 April 2024.
On conclusion of the inspection, the company has received five inspectional observations in Form 483, where none of the observations are related to data integrity. The company will work closely with US FDA in resolving all points, the pharmaco stated in the press release.
There is no impact on financial, operation or other activities of the company pursuant the observations received, added the firm.
Aarti Drugs is primarily involved in manufacturing and marketing of active pharmaceutical ingredients (API), pharma intermediates and specialty chemicals.
The pharmaceutical companys consolidated net profit rose marginally to Rs 36.67 crore in Q3 FY24 as compared with Rs 36.68 crore recorded in Q3 FY23. Revenue from operations fell 8.7% to Rs 605.94 crore in Q3 FY24 as compared with Rs 663.96 crore posted same period a year ago.
Shares of Aarti Drugs rose 1.14% to Rs 498.80 on the BSE.
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