Aurobindo Pharma arm Secures USFDA Approval for Anesthetic Drug

The pharmaceutical company announced that its subsidiary, Eugia Steriles, received approval from the USFDA for its first product, Lidocaine Hydrochloride injection. Lidocaine is a numbing medication used as a local anesthetic to reduce pain or discomfort during medical procedures like surgery, needle punctures, or insertion of catheters or breathing tubes.

The new injectable facility of Eugia Steriles (a 100% subsidiary of Eugia Pharma Specialities and a stepdown subsidiary of the company), situated at Parawada Mandal, Anakapalli district, Andhra Pradesh, which was inspected by the US FDA from 28 March 2024 to 5 April 2024, has now received its first product approval from the US FDA for Lidocaine Hydrochloride injection, USP, 1% (10 mg/mL) and 2% (20 mg/mL), Aurobindo Pharma stated.

The submission of the sANDA was for Prior Approval Supplement to include a new facility for manufacturing, labeling, packaging, and testing of a different drug product. Aurobindo Pharma's main focus is on producing and selling active pharmaceutical ingredients, generic pharmaceuticals, and related services.

In Q1 FY25, the pharmaceutical firm recorded a 61.05% increase in total net income to Rs 919.22 crore with a 9.82% growth in revenue to Rs 7,457.65 crore compared to Q1 FY24.