Demand for the drug has skyrocketed in recent weeks after more people contracted the fungal infection.
A new Amphotericin B Liposome 50 mg injection drug application filed by the Taiwanese clinical-stage specialty pharmaceutical company TLC, registered with Nasdaq, has been approved by the Central Drugs Standard Control Organization (CDSCO) of India.
The approval is for “immediate importation by approved use and indication, to help the country cope with an acute shortage of liposomal amphotericin B,” the Strides group said Thursday. Liposomal amphotericin B injection is indicated for mucormycosis, also known as black fungus. Demand for the drug has skyrocketed in recent weeks after more people contract the fungal infection.
The approved product is known as Ampholipad in Taiwan and AmphoTLC in India. After approval, AmphoTLC will be imported from Taiwan by Stelis Biopharma, the biotech arm of the Strides group, and launched and distributed immediately in India, according to a statement.
Strides CEO and Managing Director R. Ananthanarayanan said that “CDSCO’s approval allows us to import and distribute the product immediately in India and help alleviate the crisis resulting from an unprecedented increase in cases of mucormycosis linked to Covid-19. We have further expanded our COVID-19 portfolio with the TLC partnership. ”
TLC appreciates the support of the Indian authorities who “have thoroughly and expeditiously approved AmphoTLC,” said its founder, chairman and CEO Keelung Hong. Shipments of the drug to India will begin immediately, he said.