The drug maker on Wednesday announced that the United States Food and Drug Administration (US FDA) inspected its wholly owned subsidiary, APL Health Care's Unit I & III, at Jadcherla in Telangana, during 9 January to 18 January 2023.
In a regulatory filing, Aurobindo Pharma said that the US FDA has inspected its subsidiary, APL Health Care's Unit I & III, an orals (tablets, capsules and soft gel capsules) and derma manufacturing facility located at Jadcherla, Mahabub Nagar district, Telangana, from 9 January to 18 January 2023.
At the end of the inspection, The US drug regulator issued a 'Form 483' with 2 observations. The observations are procedural in nature, said the company.
We will respond to the US FDA within the stipulated timelines and work closely with US FDA to close the observations at the earliest, the pharmaceutical company stated.
Aurobindo Pharma develops, manufactures and distributes generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients.
The pharmaceutical company reported 41.3% fall in consolidated net profit to Rs 409.45 crore on a 3.7% decline in net sales to Rs 5,673.65 in Q2 FY23 over Q2 FY22.
Also Read
Shares of Aurobindo Pharma were up 0.35% to Rs 445.60 on the BSE.
Powered by Capital Market - Live News
Disclaimer: No Business Standard Journalist was involved in creation of this content