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 Diazepam Rectal Gel, 10 mg and 20 mg, Rectal Delivery System, a generic equivalent of Diastat AcuDial Rectal Delivery System, 10 mg and 20 mg, of Bausch Health US, LLC.
Diazepam Rectal Gel (RLD Diastat AcuDialTM) had estimated annual sales of $34 million in the U.S. (IQVIA MAT March 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.
