Lupin’s wholly-owned subsidiary--Novel Laboratories Inc., based in Somerset, New Jersey, has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Fluocinolone Acetonide Oil, 0.01% (Body Oil), a generic equivalent of Derma-Smoothe/FS 0.01% (Body Oil), of Hill Dermaceuticals, Inc. This product will be manufactured at Lupin’s Somerset facility in the US. Fluocinolone Acetonide Oil (RLD Derma-Smoothe/FS) had estimated annual sales of $10 million in the U.S. (IQVIA MAT June 2023).
Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.
