A new injectable facility of Aurobindo Pharma’s subsidiary Eugia Steriles has received its first product approval from the United States Food and Drug Administration.
The U.S. FDA inspected the unit in Parawada mandal of Anakapalli district, Andhra Pradesh, from March 28 to April 5. It has now received its first product approval from the U.S. FDA for Lidocaine Hydrochloride Injection, USP, 1% (10 mg/mL) and 2% (20 mg/mL).
The sANDA (supplemental abbreviated new drug application) was submitted as Prior Approval Supplement for addition of an alternate drug product manufacturing, labelling, packaging and testing facility, Aurobindo Pharma said in a filing on Wednesday.
Published - September 11, 2024 01:46 pm IST
