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Eugia Steriles receives its first product approval from USFDA for Lidocaine Hydrochloride Injection

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Aurobindo Pharma announced that the 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 28 March 2024 to 05 April 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.

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First Published: Sep 11 2024 | 12:15 PM IST

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