Aurobindo Pharma subsidiary bags USFDA nod for Amphotericin B Liposome for Injection

Hyderabad: Aurobindo Pharma Limited has announced that its wholly-owned subsidiary company, Eugia Pharma Specialities Limited, has received final approval from the US Food & Drug Administration (USFDA) for Amphotericin B Liposome for Injection, 50 mg.

Amphotericin B Liposome for Injection, 50 mg/vial Single-Dose Vial to be bioequivalent and therapeutically equivalent to the reference listed drug (RLD), AmBisome Liposome for Injection, 50 mg/vial, of Astellas Pharma US, Inc.

The product is expected to be launched by Q4 FY23. The approved product has an estimated market size of around US$ 145 million for the twelve months ending September 2022, according to IQVIA.

This is a partnership product from TTY Biopharm Company Limited and will be manufactured at their Taiwan facility and marketed by Eugia Pharma. This is the 152nd ANDA (including 10 tentative approvals received) out of Eugia Pharma Speciality Group (EPSG) facilities, manufacturing both oral and sterile specialty products.

Amphotericin B Liposome for Injection is indicated for the following conditions:

• Empirical therapy for presumed fungal infection in febrile, neutropenic patients.

• Treatment of Cryptococcal Meningitis in HIV-infected patients.

• Treatment of patients with Aspergillus species, Candida species, and/or Cryptococcus species infections refractory to amphotericin B deoxycholate, or in patients where renal impairment or unacceptable toxicity precludes the use of amphotericin B deoxycholate.

• Treatment of visceral leishmaniasis. In immunocompromised patients with visceral leishmaniasis treated with amphotericin B liposome for injection, relapse rates were high following the initial clearance of parasites.

Aurobindo Pharma Limited is a global pharmaceutical company headquartered in Hyderabad, India. The Company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals, and active pharmaceutical ingredients globally in over 155 countries.

The company has 27 manufacturing and packaging facilities that are approved by leading regulatory agencies, including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, and Brazil ANVISA. The company's product portfolio is spread over 7 major therapeutic/product areas encompassing CNS, Anti-Retroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics, and Anti-Allergic.

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