26 May 2021 | News
AmphoTLC™ will address the country’s acute liposomal amphotericin B shortage
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TLC, a Taiwan & US-based clinical-stage specialty pharmaceutical company developing novel nanomedicines to target areas of unmet medical need, and Zydus Healthcare Limited, part of Zydus Cadila group have announced the signing of a license supply and commercialization agreement to commercialize AmphoTLC™ (Amphotericin B Liposome for Injection 50mg) in India.
Under the terms of the agreement, TLC will manufacture and supply AmphoTLC™ on a non-exclusive basis to Zydus, and Zydus will commercialize AmphoTLC™ in India.
AmphoTLC™ is the first and only complex generic drug to have achieved bioequivalence to Gilead’s AmBisome®, proving its sameness to the safest form of amphotericin B in the world.
With the recent surge of infections in India, AmphoTLC™ will address the country’s acute liposomal amphotericin B shortage.
TLC has obtained the necessary approvals for AmphoTLC™ from the regulatory authorities in India with the assistance of Zydus, including a new drug registration with Central Drugs Standard Control Organization (CDSCO) on May 25, 2021, for immediate importation as per approved usage and indication of liposomal amphotericin B.
Speaking on the development, Dr. Sharvil Patel, Managing Director of Cadila Healthcare Ltd., said, “With India facing an acute shortage of the drug to treat mucormycosis, we are making this critical drug available in India on an immediate basis. The need of the hour is to tackle this life-threatening infection with a safe and effective therapy.”