Aurobindo Pharma has informed that 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 March 28, 2024 to April 05, 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). The sANDA was submitted as ‘Prior Approval Supplement’ for addition of an alternate drug product manufacturing, labeling, packaging, and testing facility.
The above information is a part of company’s filings submitted to BSE.
