On Wednesday Aurobindo Pharma said that the US health regulator has issued a Form 483 with one observation after inspecting a formulation production facility of its unit in Andhra Pradesh.
The US Food and Drug Administration (US FDA) inspected Unit IV of APL Healthcare Ltd, a wholly-owned subsidiary of the company, in Tirupati district of Andhra Pradesh from September 13-19, 2023, the Hyderabad-based drug major said in a regulatory filing.
At the end of the inspection, a Form 483 was issued with one observation which is procedural in nature, it added.
“We will respond to the US FDA within the stipulated timelines and work closely with US FDA to close the observation at the earliest,” Aurobindo Pharma stated.
As per the 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 may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
Shares of Aurobindo Pharma closed 0.37 per cent down at Rs 891.50 apiece on the BSE.
Aurobindo Pharma Ltd. is a speciality and generic drug medicine manufacturing company. The company’s product line covers a range of therapeutic specialities. The United States generates the great bulk of the company’s sales, followed by Europe. The majority of Aurobindo’s sales come from its formulations division, and the remaining portion comes from its operations involving active pharmaceutical ingredients.