Aurobindo Pharma Ltd on Wednesday 11 September announced that its new injectable facility in Andhra Pradesh has secured its first product approval from the US Food and Drug Administration (USFDA). 

The new facility is Eugia Steriles, a wholly-owned subsidiary of Eugia Pharma Specialties and a step-down subsidiary of the company. 

Eugia Steriles has secured its first USFDA approval for Lidocaine Hydrochloride injection. The US regulator has conducted an inspection at Eugia Steriles between 28 March and 5 April. 

Aurobindo Pharma recently submitted a Supplemental Abbreviated New Drug Application (sANDA) for a “Prior Approval Supplement,” seeking to add an alternate facility for drug manufacturing, labelling, packaging, and testing. 

Earlier last month, the company’s Eugia Pharma manufacturing facility (Unit-III) received a warning letter from the USFDA, following a previous “Official Action Indicated” (OAI) status issued in May this year after an inspection. 

The OAI status signals significant regulatory concerns that require resolution.

Discover the next big investment! Unicorn Signals’ IPO screener helps you identify promising initial public offerings. Download Unicorn Signals and get ahead of the curve! Sign Up Now & Find Your Next IPO Gem!