Sep 11, 2024
The pharma major announced that its stepdown subsidiary, Eugia Steriles received its first product approval from the United States Food and Drug Administration (USFDA) for Lidocaine Hydrochloride injection.
Lidocaine is a local anesthetic (numbing medication) that is used to numb an area of your body to help reduce pain or discomfort caused by invasive medical procedures such as surgery, needle punctures, or insertion of a catheter or breathing tube.
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 sANDA was submitted as Prior Approval Supplement for addition of an alternate drug product manufacturing, labeling, packaging, and testing facility.
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 QI FY25 over QI FY24.
Source: Business Standard