Aurobindo Pharma subsidiary bags USFDA nod for Amphotericin B Liposome for Injection
This is a partnership product from TTY Biopharm Company Limited and will be manufactured at their Taiwan facility and marketed by Eugia Pharma.;
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.
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.