TLC has obtained the necessary approvals for AmphoTLC ™ from regulatory authorities in India
Taiwanese company TLC and India-based Strides Pharma Science have entered into a licensing and commercialization agreement to commercialize AmphoTLC ™ (Amphotericin B Liposome for Injection 50mg) in India.
Under the non-exclusive agreement, AmphoTLC ™ supplied by TLC will be imported from Taiwan by Stelis Biopharma Private Limited (Stelis), the biotechnology arm of the Strides group, and will be immediately launched and distributed in India by Strides.
TLC obtained the necessary approvals for AmphoTLC ™ from regulatory authorities in India, including a new drug registration with the Central Drugs Standard Control Organization (CDSCO) of India on May 25, 2021, for immediate import in accordance with the approved use and indication for 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 CDSCO approval allowed us to import and immediately distribute the product in India and help alleviate the crisis stemming from an unprecedented increase in mucormycosis cases linked to COVID-19. We have further expanded our COVID-19 portfolio with the TLC partnership and strengthened our efforts and commitment to tackle 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 every year; Marketing authorization for the drug in China is under review. T