Aurobindo Pharma Ltd. announced on Wednesday that a new injectable facility of Eugia Steriles Private Ltd., which was inspected by the US Food and Drug Administration, received its first product approval, according to the firm's press release.
Eugia Steriles Private Limited is a 100% subsidiary of Eugia Pharma Specialities Limited and a step-down subsidiary of Aurobindo Pharm.
The plant located in Andhra Pradesh was inspected by the USFDA from March 28 to April 5 of this year.
The FDA approved Lidocaine Hydrochloride Injection, USP, 1% (10 mg/mL) and 2% (20 mg/mL).
The supplemental Abbreviated New Drug Application for the product was submitted as 'Prior Approval Supplement' for the addition of an alternate drug product manufacturing, labelling, packaging, and testing facility.
(With Inputs From PTI)
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