Cadila Healthcare (also known as Zydus Cadila) has signed a license supply and commercialization agreement with Taiwanese pharma company TLC to commercialize the latter’s Black Fungus drug – AmphoTLC (Amphotericin B Liposome for Injection 50mg) in India.
As per the terms of the deal, TLC will manufacture and supply AmphoTLC on a non-exclusive basis to Zydus Cadila with the latter to commercialize the Black Fungus medicine in India.
India’s Central Drugs Standard Control Organization (CDSCO) of India has approved TLC’s new drug application (NDA) for Amphotericin B Liposome for Injection 50mg or AmphoTLC for immediate importation as per approved usage and indication.
AmphoTLC is a liposomal amphotericin B injection, which has been indicated for mucormycosis and other severe systemic fungal infections. Approved in Taiwan, the drug for several years has been manufactured and sold by Yung Shin Pharmaceutical Industrial.
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.”
According to Zydus Cadila, AmphoTLC is the first generic drug to have achieved bioequivalence to Gilead Sciences’ AmBisome.
Zydus Cadila said that with the surge of Black Fungus infections in India in Covid-19 patients, AmphoTLC will address the acute shortage of liposomal amphotericin B.
Dr. Sharvil Patel – Managing Director of Cadila Healthcare 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.”
Earlier this week, Everest Organics Limited said that it has developed and launched an anti-fungal API called Posaconazole for the treatment of black fungus associated with Covid-19 patients.
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