AmphoTLC is a liposomal amphotericin B injection used to treat severe systemic fungal infections like black fungus
Strides Pharma Science has partnered with TLC, a Taiwan-based specialty pharmaceutical company, to supply Liposomal Amphotericin B, a drug used to treat mucormycosis (black fungus), to India.
Strides and TLC stated in a joint statement on Thursday that the Central Drugs Standard Control Organization (CDSCO) has accepted TLC's new drug application (NDA) for Amphotericin B Liposome for Injection 50 mg in India for immediate importation per approved use and indication.
Mucormycosis, often called black fungus, is a serious fungal infection, and Covid-19 related mucormycosis is life-threatening, according to the 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," Strides CEO and MD R Ananthanarayanan said.
AmphoTLC will be imported from Taiwan by Stelis Biopharma Pvt. Ltd, Strides' biotech arm, and will be launched and distributed in India by Strides immediately, according to the company.
"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," TLC President George Yeh said.
According to the statement, AmphoTLC is a liposomal amphotericin B injection used to treat severe systemic fungal infections including mucormycosis.
Strides Pharma Science's shares were trading at Rs 816.70 on the BSE, up 0.50 per cent from its previous close.