Aurobindo Pharma arm gets warning letter from USFDA for formulations unit in Telangana

Aurobindo Pharma Ltd on Friday said its arm Eugia Pharma Specialities Ltd received a warning letter from the US health regulator for its formulations manufacturing unit in Telangana. Earlier in May, the company had stated that Unit-III, a formulation manufacturing facility of Eugia Pharma Specialities Ltd., a wholly-owned subsidiary, received Official Action Indicated (OAI) status by the US Food and Drug Administration (USFDA).

"Subsequent to OAI, the unit has received a warning letter," Aurobindo Pharma said in a regulatory filing. It did not elaborate on the details of the warning by the regulator. "There is no impact on the existing supplies to the US markets," the company said. 

Aurobindo Pharma said it remains committed to working closely with the USFDA and continues to enhance its compliance on an ongoing basis. The USFDA had conducted an inspection at Unit-III, a formulation manufacturing facility of Eugia Pharma Specialities Ltd, located at Pashamylaram, Patancheru Mandal, Sangareddy district in Telangana, from January 22 to February 2, 2024. 

Subsequently, the USFDA had determined the inspection classification status of this facility as 'Official Action Indicated (OAI)'. As per the USFDA, OAI implies that the regulator may withhold approval of any pending product applications or supplements filed from such facility till the outstanding observations related to non-compliance with manufacturing norms laid down by it.