Lupin receives US FDA approval for Modafinil 100 mg, 200 mg tablets

Drug firm Lupin Ltd on Friday (September 4) said it has received United States Food and Drug Administration (US FDA) approval for Modafinil Tablets USP, 100 mg and 200 mg.

The US FDA has approved Lupin’s Modafinil Tablets as bioequivalent to Provigil Tablets, the reference listed drug of Nuvo Pharmaceuticals (Ireland) DAC.

Modafinil Tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA) or shift work disorder (SWD).

According to IQVIA data cited by Lupin, Modafinil Tablets, with Provigil as the reference listed drug, had estimated annual sales of $70.7 million in the US based on the July 2026 Moving Annual Total (MAT).

First Quarter Results

The pharmaceutical company reported a 16.1% year-on-year increase in net profit to ₹1,415 crore, compared with ₹1,219 crore in the year-ago quarter. Revenue from operations surged 33.3% YoY to ₹8,217 crore from ₹6,164 crore, supported by healthy growth across key markets.

Operating performance was even stronger, with EBITDA rising 47.3% to ₹2,390 crore from ₹1,623 crore a year earlier. Consequently, EBITDA margin expanded by 280 basis points to 29.1%, compared with 26.3% in Q1FY26.

Geographically, the US business remained the largest contributor, with revenue rising to $366 million from $282 million a year ago. Domestic sales in India increased 14% to ₹2,379.6 crore, while other developed markets recorded 48.3% growth to ₹1,149.4 crore.

Emerging markets also delivered strong momentum, with revenue climbing 51.7% to ₹989.7 crore. Lupin invested ₹607.7 crore, or 7.4% of sales, in research and development during the quarter, while capital expenditure stood at ₹278.6 crore.

Shares of Lupin Ltd ended at ₹2,111.00, down by ₹24.00, or 1.12%, on the BSE.