The ANDA approved by United States Food and Drug Administration (USFDA) is a generic equivalent of Diastat AcuDial rectal delivery system of Bausch Health US, LLC.

Diazepam Rectal Gel is used in emergency situations to stop cluster seizures (episodes of increased seizure activity) in people who are taking other medications to treat epilepsy (seizures).

According to IQVIA MAT March 2023, Diazepam Rectal Gel (RLD Diastat AcuDialTM) had estimated annual sales of $34 million in the U.S.

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

The company reported consolidated net profit of Rs 235.96 crore in Q4 FY23 as compared with net loss of Rs 517.98 crore in Q4 FY22. Net sales jumped 12.1% to Rs 4,330.30 crore in Q4 FY23 as against Rs 3,864.50 crore in Q4 FY22.

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