Strides Pharma Science and Taiwan-based specialty pharmaceutical firm TLC have partnered to launch Liposomal Amphotericin B, a drug used in the treatment of mucormycosis (black fungus), in India.
The Central Drugs Standard Control Organization (CDSCO) has approved TLC’s new drug application (NDA) of Amphotericin B Liposome for Injection 50mg in India for immediate importation per approved usage and indication, Strides and TLC said in a joint statement.
“This 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,” said R Ananthanarayanan, CEO and MD, Strides.
Mucormycosis is a serious fungal infection, also known as black fungus, and COVID-19 associated mucormycosis is life-threatening, the statement said.
AmphoTLC will be imported from Taiwan by Stelis Biopharma, the biotech arm of Strides group, and will be launched and distributed in India immediately by Strides, it added.
“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. We are glad that the result of years of our hard work can help India in its times of need,” George Yeh, President, TLC said.
AmphoTLC is a liposomal amphotericin B injection indicated for severe systemic fungal infections such as mucormycosis, the statement said.
(Edits by EP News Bureau)