Ampholipad™

According to The Lancet, fungal infections affect more than a billion people each year, resulting in approximately 11.5 million life-threatening infections and more than 1.5 million deaths annually. Gilead Sciences’ AmBisome® (liposomal amphotericin B) is the most popular antifungal medication used for serious fungal infections and leishmaniasis, with global sales reaching US$420 million in 2018. Although 23 years have passed since AmBisome® first entered the market, a generic version has yet to been seen in China, Europe, and the US due to its complex formulation and chemistry and manufacturing control techniques. TLC’s Ampholipad™ Liposome for Injection 50mg, a generic of AmBisome®, has been approved and marketed in Taiwan for more than six years.

Ampholipad™ is a generic of AmBisome®, a lipid-encapsulated version of the antifungal drug amphotericin B. Ampholipad™ successfully demonstrated bioequivalence to AmBisome® in all three forms and in both large and small batches, making it the first and only drug to have achieved such a feat. Scaled-up production of Ampholipad™ can surpass a million vials each year, at a capacity capable of meeting increasing global demands.

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API

Amphotericin B

DDS Platform

NanoX™

Indication

Systemic fungal infection

Advantage

  • Bioequivalent to AmBisome®
  • Production at over 1 million vials a year

Development Status

Marketed