Lupin Launches Diazepam Rectal Gel in US Markets

The unveiling of diazepam rectal gel, available in doses of 10 mg and 20 mg, has been declared by Lupin Limited, a prominent global pharmaceutical company. This release comes after their subsidiary, Novel Laboratories Inc., located in Somerset, New Jersey, obtained approval for its abbreviated new drug application (ANDA) from the United States Food and Drug Administration (FDA).

The generic version of Bausch Health US, LLC's Diastat AcuDial rectal delivery system, which comes in 10 mg and 20 mg, is known as Diazepam rectal gel. According to IQVIA's MAT report of September 2023, sales of Diastat AcuDial, a rectal gel medication containing Diazepam, reached approximate annual revenue of USD 37 million within the United States. Based in Mumbai, India, Lupin is a forward-thinking multinational pharmaceutical company driven by innovation.

The company engages in the development and commercialization of diverse branded and generic formulations, biotech products, and APIs in more than 100 markets across the United States, India, South Africa, and various regions including Asia Pacific (APAC), Latin America (LATAM), Europe, and the Middle East, as per pharmabiz. In the year 1968, Dr. Desh Bandhu Gupta (affectionately known as DBG) founded the company in India, marking the commencement of Lupin's remarkable expedition. In the year 1979, the company initiated its operations with a single facility located in Aurangabad. However, as time progressed, the company has expanded its infrastructure and currently boasts a remarkable total of 11 modern manufacturing facilities spread across the nation. The scientists and research and development (R&D) personnel at the company's two research centres in Pune and Aurangabad make use of advanced technology to offer exceptional solutions, especially in the realm of affordable biosimilars of superior quality.