Aurobindo Pharma's Subsidiary Receives First Product Approval from USFDA for Lidocaine Hydrochloride Injection

Aurobindo Pharma Ltd. has announced that its stepdown subsidiary, Eugia Steriles Private Limited, has received its first product approval from the United States Food and Drug Administration (US FDA) for Lidocaine Hydrochloride Injection, USP, 1% (10 mg/mL) and 2% (20 mg/mL). The new injectable facility of Eugia Steriles Private Limited, situated at Parawada Mandal, Anakapalli District, Andhra Pradesh, was inspected by the US FDA from March 28, 2024 to April 05, 2024, and the sANDA was submitted as ‘Prior Approval Supplement’ for addition of an alternate drug product manufacturing, labeling, packaging, and testing facility.