Aurobindo Pharma's arm gets USFDA's approval for Posaconazole Injection

27 Dec 2023 Evaluate

Aurobindo Pharma's wholly owned subsidiary company -- Eugia Pharma Specialities has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Posaconazole Injection, 300 mg/16.7 mL (18 mg/mL), Single-Dose Vial, which is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Noxafil Injection, 300 mg/16.7 mL (18 mg/mL), of Merck Sharp & Dohme LLC (Merck). 

The product is expected to be launched in December 2023. The approved product has an estimated market size of $25.4 million for the twelve months ending October 2023, according to IQVIA. This is the 173rd ANDA approval (including 8 tentative approvals received) out of Eugia Pharma Specialities Group (EPSG) facilities, manufacturing both oral and sterile specialty products. 

Aurobindo Pharma is engaged in manufacturing pharmaceutical products. It offers active pharmaceutical ingredients, intermediates and generic formulations like astemizole, domeperidone and omeprazole; anti-infective, oral and sterile antibiotics, pain management and osteoporosis segments.


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