Aurobindo Pharma said on Friday that its wholly-owned subsidiary Eugia Pharma Specialties had received final approval from the United States Food and Drug Administration (USFDA) for amphotericin B liposomes injection. Injections are used to treat fungal infections.

The 50 mg/vial single-dose vial will be bioequivalent and therapeutically equivalent to the reference marketed drug from Astellas Pharma US, Inc. Aurobindo Pharma expects to launch the product in the March quarter of the current financial year.

Liposomal amphotericin B for injection is used to treat fungal infections such as cryptococcal meningitis and visceral leishmaniasis. This is a collaborative product of TTY BioPharm Company Ltd, which will be manufactured at its Taiwan factory and sold by Eugia Pharma.

According to IQVIA, the market size of injection is estimated to be approximately $145 million for the 12 months ending September 2022.

This is the 152nd Abbreviated New Drug Application (ANDA) approved by the USFDA, including ten tentative approvals, from the Eugia Pharma Specialty Group facility, which manufactures oral and sterile speciality products.

Earlier this week, Aurobindo Pharma announced that its manufacturing facility located in the Srikakulam district of Pydibhimavaram Srikakulam in Andhra Pradesh received the USFDA’s Establishment Inspection Report (EIR). Shares of Aurobindo Pharma closed 1.1% lower at Rs 468.95.