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Aurobindo Pharma arm gets USFDA nod for fungal infection treatment injection

Aurobindo Pharma arm gets USFDA nod for fungal infection treatment injection

Aurobindo Pharma arm gets USFDA nod for fungal infection treatment injection
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By CNBCTV18.com Nov 19, 2022 8:40:35 AM IST (Published)

The product is expected to be launched by Q4 FY23.  

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Aurobindo Pharma, on Friday, said that its wholly-owned subsidiary Eugia Pharma Specialities has received final approval from the United States Food and Drug Administration (USFDA) for Amphotericin B Liposome for injection. The injection is used for the treatment of fungal infections.


The 50 mg/vial single-dose vial will be bioequivalent and therapeutically equivalent to the reference listed drug of Astellas Pharma US, Inc.

Aurobindo Pharma expects to launch this product in the March quarter of the current financial year.

Amphotericin B Liposome for Injection is used to treat fungal infections like cryptococcal meningitis and visceral leishmaniasis.  This is a partnership product from TTY Biopharm Company Ltd. and will be manufactured at their Taiwan facility and marketed by Eugia Pharma.

According to IQVIA data, the injection has an estimated market size of around $145 million for the 12 months period that ended in September 2022.

This is the 152nd Abbreviated New Drug Application (ANDA) approval from USFDA, including 10 tentative approvals, received out of Eugia Pharma Speciality Group facilities, manufacturing both oral and sterile specialty products.

Earlier this week, Aurobindo Pharma announced that it received an Establishment Inspection Report (EIR) from the USFDA for its manufacturing facility in the Pydibhimavaram Srikakulam district of Andhra Pradesh.

Shares of Aurobindo Pharma ended 1.1 percent lower at Rs 468.95.

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