Aurobindo Pharma’s Subsidiary Secures USFDA Nod for Injectable Plant

18 Sep 2024 , 04:14 PM

Aurobindo Pharma’s subsidiary, Eugia Sterlite Pvt. Ltd., received an Establishment Inspection Report (EIR) from the USFDA for its new injectable facility in Parawada Mandal, Anakapalli, Andhra Pradesh.

The EIR follows a pre-approval inspection conducted between March 28 and April 5, 2024. Aurobindo Pharma confirmed that the USFDA inspection is now closed.

Eugia Steriles is a fully-owned subsidiary of Eugia Pharma Specialities Ltd., which is a step-down subsidiary of Aurobindo Pharma. On September 11, Aurobindo announced USFDA approval for Eugia Steriles’ Lidocaine Hydrochloride Injection USP (1% and 2%) following the inspection.

The approval was based on a supplemental Abbreviated New Drug Application (sANDA) for an alternate facility for manufacturing and testing.

Eugia Pharma’s Unit-III facility in Telangana was previously issued an Official Action Indicated (OAI) status by the USFDA in August 2024, signaling serious regulatory concerns.

Aurobindo Pharma’s net sales for June 2024 grew 10.46% to ₹7,567.02 crore compared to ₹6,850.52 crore in June 2023. Quarterly net profit surged by 61.05% to ₹919.22 crore, and EBITDA rose 45.18% to ₹1,840.50 crore for the same period.