The drug maker on Thursday announced that announced that the Central Drugs Standard Control Organization (CDSCO) of India has approved TLC's New Drug Application (NDA) of Amphotericin B Liposome for injection 50 mg.
AmphoTLC 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.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 Pharma Sciences.
With a soaring number of COVID‐19 infections in India, the number of COVID‐19 associated mucormycosis (CAM) cases has also been on the rise. Mucormycosis is a serious fungal infection also known as "black fungus". It has emerged as a post‐COVID complication, infecting about 30% of COVID patients who are diabetic or otherwise immunocompromised. If the progression of infection is not treated early, over 60% of patients could die.
George Yeh, President of TLC said, "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. With this approval and prompt delivery of our product, thousands of patients will have the opportunity to receive early treatment with AmphoTLC, reducing the fatality rate brought on by the sudden influx of mucormycosis."
Dr R Ananthanarayanan, CEO and MD of Strides, said, "We are pleased to partner with TLC for the distribution of liposomal amphotericin B. 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. We have expanded our Covid‐19 portfolio further with the TLC partnership and reinforced our effort and commitment to fight against this global pandemic."
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TLC is a clinical-stage specialty pharmaceutical company developing novel nanomedicines to target areas of unmet medical need.
Strides is a global pharmaceutical company headquartered in Bengaluru, India. The company mainly operates in the regulated markets and has an in Africa for Africa strategy along with an institutional business to service donor-funded markets. The company's global manufacturing sites are located in India (Chennai, Puducherry and two locations in Bengaluru), Singapore, Italy (Milan), Kenya (Nairobi) and the United States (Florida).
On a consolidated basis, the pharma company posted a 61.9% fall in net profit to Rs 35.16 crore on a 13.6% rise in net sales to Rs 832 crore in Q3 FY21 over Q3 FY20.
Shares of Strides Pharma Science were up 0.89% at Rs 819.80 on BSE.
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