With soaring number of Covid-19 infections and Covid-19 associated mucormycosis (CAM) (black fungus) cases, Strides Pharma Science has partnered with TLC, a Nasdaq listed clinical-stage specialty pharmaceutical company, to launch Amphotericin B Liposome which is used to treat the infection.
The company on Thursday, announced that the Central Drugs Standard Control Organization (CDSCO) in India has approved TLC’s New Drug Application (NDA) of Amphotericin B Liposome for Injection 50mg (known as Ampholipad in Taiwan and AmphoTLCTM in India) for immediate import as per approved usage and indication.
Strides Pharma Science spokesperson said, “The product AmphoTLCTM will be imported from Taiwan by Stelis Biopharma Private Limited (Stelis), the biotech arm of Strides group, and will be launched and distributed in India immediately by Strides.”
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AmphoTLCTM is a liposomal amphotericin B injection indicated for severe systemic fungal infections such as mucormycosis. The drug is approved in Taiwan and has been marketed and sold for several years, with a steady increase in the market share each year; market authorisation of the drug in China is under review.
The approval of AmphoTLCTM in India follows the conduct of complete due diligence by regulators in India based on the numerous years of development TLC has dedicated and its quality performance in the developed markets.
“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 Covid19 related mucormycosis cases. We have expanded our Covid-19 portfolio further with the TLC partnership and reinforced our effort and commitment to fight against this global pandemic,” said Dr R Ananthanarayanan, CEO and Managing Director, Strides.
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George Yeh, President, TLC said, “AmphoTLCTM 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. With this approval and prompt delivery of our product, thousands of patients will have the opportunity to receive early treatment with AmphoTLCTM, reducing the fatality rate brought on by the sudden influx of mucormycosis.”