Aurobindo Pharma-led arm Eugia Pharma gets USFDA approval for Icatibant Injection; stock gains

16 Aug 2023 , 12:50 PM

Eugia Pharma Specialities Limited, a wholly owned subsidiary of Aurobindo Pharma Limited, has received final USFDA approval to manufacture and market Icatibant Injection, available in, 30 mg/3 mL (10 mg/mL), Single-Dose Prefilled Syringe.

Icatibant Injection is bioequivalent and therapeutically equivalent to the reference listed drug (RLD) FIRAZYR (Icatibant Injection) by Takeda Pharmaceuticals USA Inc, the company announced on Wednesday through a filing with the bourses.

The product will be available in September 2023. According to IQVIA, the approved product has a market size of roughly US$ 137 million as of June 2023.

This is the 166th ANDA (along with nine tentative approvals) from Eugia Pharma Speciality Group (EPSG) facilities, which produce both oral and sterile specialty pharmaceuticals.

At around 12.43 PM, Aurobindo Pharma was trading 1.30% higher at Rs 883, against the previous close of Rs 871.65 on NSE. The counter touched an intraday high of Rs 883.65 and an intraday low of Rs 855.05.

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