Cadila Healthcare (Zydus Cadila), on May 26 announced the signing of a licence for supply and commercialisation agreement with Taiwan-based drug maker TLC to commercialise the latter's Amphotericin B Liposome Injection 50mg (AmphoTLC) in India.
Under the terms of the agreement, TLC will manufacture and supply AmphoTLC on a non-exclusive basis to Zydus, and Zydus will commercialise the antifungal drug in India.
Amphotericin B Liposome Injection is a critical drug to treat Mucormycosis or Black Fungus in India. The drug is facing a severe shortage due to the rise in Black Fungus cases in India. The Central government is importing about 6.8 lakh vials and approved applications of 5 drug makers including TLC to supply the drug. Some of the states like Maharashtra have also announced that they will be importing Amphotericin B Liposome Injection.
Zydus said 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.
The drug is approved in Taiwan and has been manufactured and sold by Yung Shin Pharmaceutical Industrial Co. (YSP) for several years.
The approval of AmphoTLC in India follows the conduct of comprehensive due diligence by regulators in India based on the numerous years of development TLC has dedicated as well as its quality performance in the developed markets.
“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,” said Sharvil Patel, Managing Director, of Cadila Healthcare.
Mucormycosis is a serious fungal infection also known as black fungus, and COVID Associated Mucormycosis is a life-threatening form of mucormycosis which has emerged as a post-COVID complication, infecting about 30 percent of COVID patients who are diabetic or otherwise immunocompromised. If the progression of the infection is not treated early, over 60 percent of patients could die.