In May 2024, the United States Food and Drug Administration (US FDA) had conducted an inspection at Unit-III, a formulation manufacturing facility, of Eugia Pharma Specialities, a wholly owned subsidiary of the company, situated at Pashamylaram, Patancheru Mandal, Sangareddy District, Telangana, from 22 January to 2 February 2024.
Subsequently, the US FDA has determined the inspection classification status of this facility as ‘official action indicated (OAI)’.
In a regulatory filing made during market hours today, Aurobindo Pharma stated that subsequent to OAI, the aforementioned unit has now received a warning letter.
"There is no impact on the existing supplies to the US markets,” Aurobindo Pharma said in a statement.
The company remains committed to work closely with the US FDA and continues to enhance its compliance on an ongoing basis.
Aurobindo Pharma is principally engaged in manufacturing and marketing of active pharmaceutical ingredients, generic pharmaceuticals and related services.
The pharma major reported 61.05% jump in consolidated net profit to Rs 919.22 crore on a 9.82% rise in revenue from operations to Rs 7,457.65 crore in Q1 FY25 over Q1 FY24.