TLC and Strides Pharma Science Limited 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 50mg (known as Ampholipad® in Taiwan and AmphoTLCTM in India) for immediate importation per approved usage and indication, to aid in the country's emergency of acute liposomal amphotericin B shortage. 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. 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 authorization 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. With a soaring number of COVID19 infections in India, the number of COVID19 associated mucormycosis (CAM) cases has also been on the rise.

Mucormycosis is a serious fungal infection also known as "black fungus", and CAM is a life threatening form of mucormycosis which has emerged as a postCOVID 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. The increasing number of CAM cases has resulted in unprecedently high demand for liposomal amphotericin B, the key drug to treat mucormycosis, causing an acute shortage of the drug.

Exploitation by sellers on the black market, who are marking up the price of liposomal amphotericin B by three times, is further exacerbating the situation. The steep increase in price and the financial burden it brings is forcing patients to opt for conventional amphotericin B, which is known for its nephrotoxicity, with many patients having to discontinue usage due to renal toxicities. In light of the ongoing COVID19 pandemic situation and in response to the humanitarian crisis, the new drug registration for AmphoTLCTM was promptly granted in India.

The registration allows for immediate importation of AmphoTLCTM as per approved usage and indication of liposomal amphotericin B in India, including mucormycosis, to help alleviate the urgent need for the drug.