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. 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. Shipments of the drug to India will begin immediately, he said.

Source: The Hindu May 27, 2021 17:37 UTC