28 May 2021 | News
TLC has obtained necessary approvals for AmphoTLC™ from regulatory authorities in India
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Taiwanese firm TLC and Strides Pharma Science, based in India, have entered a license supply and commercialization agreement to commercialize AmphoTLC™ (Amphotericin B Liposome for Injection 50mg) in India.
Under the terms of the non-exclusive agreement, AmphoTLC™ supplied by TLC 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.
TLC has obtained necessary approvals for AmphoTLC™ from regulatory authorities in India, including a new drug registration with India’s Central Drugs Standard Control Organization (CDSCO) on May 25, 2021, for immediate importation as per approved usage and indication of liposomal amphotericin B.
“We are pleased to partner with TLC for the distribution of AmphoTLC™,” commented Dr. R. Ananthanarayanan, CEO and Managing Director of Strides. “The approval from CDSCO has allowed 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.”
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 under the name Ampholipad®, with a steady increase in market share each year; market authorization of the drug in China is under review. T