Aurobindo Pharma Ltd on Wednesday said a new injectable facility of Eugia Steriles Private Limited which was inspected by the US Food and Drug Administration (FDA) received its first product approval.
Eugia Steriles Private Limited is a 100 per cent subsidiary of Eugia Pharma Specialities Limited and a step-down subsidiary of Aurobindo Pharma.
A press release from the drugmaker said the plant located in Andhra Pradesh was inspected by the US regulator from March 28 to April 5, this year.
The FDA approved Lidocaine Hydrochloride Injection, USP, 1% (10 mg/mL) and 2% (20 mg/mL).
The SANDA (supplemental Abbreviated New Drug Application) for the product was submitted as “Prior Approval Supplement” for addition of an alternate drug product manufacturing, labeling, packaging, and testing facility.
