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TLC and Zydus Enter Agreement to Launch AmphoTLC™ in India

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2021-05-26

TLC (Nasdaq: TLC, TWO: 4152), a clinical-stage specialty pharmaceutical company developing novel nanomedicines to target areas of unmet medical need, and Zydus Healthcare Limited, part of Zydus Cadila group (Zydus) (NSE: CADILAHC) , an innovative, global pharmaceutical group that discovers, develops, manufactures and markets a broad range of healthcare therapies, today 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 India’s 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.”

Commenting on the speed of the process, George Yeh, President of TLC, said, “We would like to thank Zydus for their quick action and cooperation in enabling a swift commercialization process. TLC is glad to be able to assist in the humanitarian crisis in such a quick fashion, and as our corporate tagline – Delivering Hope for Life™ – depicts, we will be delivering the first batch of AmphoTLC™ to India to help assuage the urgent need for one of the safest and most effective antifungal drugs very soon.”

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