Pharma major Lupin receives approval from US FDA for diazepam rectal gel

Diazepam Rectal Gel had estimated annual sales of $34 million in the US



BS Web Team New Delhi

Listen to This Article

Global pharma major Lupin Limited, on Thursday, announced that its wholly-owned subsidiary, Novel Laboratories Inc, has received approval from the United States Food and Drug Administration (US FDA) for its abbreviated new drug application for diazepam rectal gel.

In a regulatory filing, the company said, “Diazepam rectal gel had estimated annual sales of $34 million in the US.”

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

In May, Lupin posted a 12 per cent year on year rise in sales for the fourth quarter of the fiscal 2022-23, and a profit after tax of Rs 242.4 crore as against a loss of Rs 511.9 crore in the corresponding quarter last fiscal.

The revenue growth came from a strong API business performance along with US and domestic market sales growth.

In Q4FY22 Lupin had posted a loss due to rising costs, price erosion in the US and impairment expense of Rs 126.7 crore for US-based Gavis.

Also Read

Brokerages downgrade Lupin post weak Q3; see up to 17% downside

Analysts turn cautious on Cipla as US FDA action delays key US launches

Lupin Pharma launches Lurasidone Hydrochloride Tablets in US

Lupin to enter cardio-vascular therapeutics space in 10 cities by Feb

Amid US watchdog heat, it is life as usual at Global Pharma'S Chennai unit

Brookfield acquires controlling stake in CleanMax Solar for $360 million

Software firm Capillary Technologies raises $45mn in Series D round

Reliance Industries, Jio among top 10 Indian brands in terms of value

TCS set for 'exciting new journey ', says new CEO & MD K Krithivasan

Manappuram Finance launches digital lending app to widen reach

The results have beat the street estimates as analysts had mostly expected the company to post a 7-8 per cent rise in revenues riding on the US business (bowel drug) and sequential improvement in the domestic market.

For the full fiscal, however, the sales growth is muted at 0.5 per cent to Rs 16,270 crore. The full year PAT came in at Rs 447.7 crore as against a loss of Rs 1509 crore in FY22. The 2021-22 numbers were impacted by the Glumetza (diabetes drug) litigation and settlement expense in the second quarter, and an impairment expense of Rs 707.7 crore for Solosec.

Commenting on the results, Nilesh Gupta, Managing Director, Lupin Limited said, “We were able to drive continued improvement in operating margins on account of improved growth in India, improvement of margins in the US as well as growth in other areas like our API business, EMEA and APAC regions.”

He added that Lupin’s India business recorded a 15 per cent growth according to IQVIA, excluding diabetes.

“In the US we improved our margins for the third quarter in a row through maximizing our portfolio, optimizing expenses and more focused R&D investment into complex products,” Gupta added.

First Published: Jun 1 2023 | 3:36 PM IST

Explore News