Aurobindo Pharma Limited on Wednesday announced that its wholly owned subsidiary company, Eugia Pharma Specialities Limited, 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 company announced through an exchange filing.
The product is expected to be launched in December 2023. The approved product has an estimated market size of US dollar 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.
About Posaconazole Injection
Posaconazole Injection, 300 mg/16.7 mL (18 mg/mL), Single-Dose Vial is indicated forthe prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versushost disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy.
Aurobindo Pharma Limited shares
The shares of Aurobindo Pharma Limited on Wednesday at 11:45 am IST were trading at Rs 1,073.55, up by 0.93 per cent.
