Aurobindo Pharma Ltd’s wholly-owned subsidiary, Eugia Pharma Specialities Ltd, has obtained 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.
The product is bioequivalent to the reference listed drug Noxafil Injection, by Merck Sharp & Dohme LLC. The approved product is set to be launched in December 2023 and had an estimated market size of US$ 25.4 million for the 12 months ending October 2023, according to IQVIA.
This marks the 173rd ANDA approval from Eugia Pharma Specialities Group (EPSG)‘s facilities, which manufactures both oral and sterile specialty products. Posaconazole Injection is indicated for the prophylaxis of invasive Aspergillus and Candida infections in severely immuno-compromised patients, such as hematopoietic stem cell transplant recipients, with graft-versus-host disease or those with hematologic malignancies undergoing chemotherapy-induced prolonged neutropenia.
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