A new drug application of Amphotericin B Liposome injection 50 mg filed by Nasdaq-listed Taiwanese clinical-stage specialty pharmaceutical firm TLC has been approved by the Central Drugs Standard Control Organization (CDSCO) of India.
The approval is for ‘immediate importation per approved usage and indication, to aid in the country’s emergency of acute liposomal amphotericin B shortage,’ the Strides Group said on Thursday. Liposomal amphotericin B injection is indicated for mucormycosis, also known as Black Fungus. The demand for the drug has soared in recent weeks following more people contracting the fungal infection.
The approved product is known as Ampholipad in Taiwan and AmphoTLC in India. Following the approval, AmphoTLC will be imported from Taiwan by Stelis Biopharma, the biotech arm of Strides Group, and introduced and distributed in India immediately, a release said.
CEO and MD of Strides R. Ananthanarayanan said the “approval from CDSCO allows us to immediately import and distribute the product in India and help ease the crisis arising out of an unprecedented rise in Covid-19 related mucormycosis cases. We have expanded our COVID-19 portfolio further with the TLC partnership. ”
TLC appreciates the support of Indian authorities who “thoroughly and expeditiously approved AmphoTLC,” said its founder, chairman and CEO Keelung Hong. Shipments of the drug to India will begin immediately, he said.
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