Pharma major Lupin Ltd on Wednesday said it has received tentative approval from the US health regulator for its generic version of Bictegravir, Emtricitabine, and Tenofovir Alafenamide tablets used to treat human immunodeficiency virus (HIV) infection. The approval by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application for Bictegravir, Emtricitabine, and Tenofovir Alafenamide tablets of strength 50 mg/200 mg/25 mg, Lupin said in a regulatory filing. This product would be manufactured at Lupin's Nagpur facility, it added. Bictegravir, Emtricitabine, and Tenofovir Alafenamide tablets, 50 mg/200 mg/25 mg are bioequivalent to Biktarvy Tablets, 50 mg/200 mg/25 mg of Gilead Sciences, Inc., and indicated for the treatment of human immunodeficiency virus infection in adults and pediatric patients weighing at least 25 kg, it added. Citing IQVIA MAT July 2025 data, Lupin said the Bictegravir, Emtricitabine, and Tenofovir Alafenamide tablets (Biktarvy) had
The announcement comes a day after Lupin said the US FDA had inspected its Nagpur injectable facility between September 8 and 16, issuing six observations
Among stocks, Natco Pharma plunged 37.85%, Ipca Labs 22.43%, Aurobindo Pharma 17.99%, and Sun Pharma 14.30%. Other laggards include Lupin (13.25%), and Dr Reddy's (5.17%).
Stocks to buy: Astra Microwave Products has shown a strong movement in the last trading session, while Lupin has recently undergone a notable resurgence
Drugmaker Lupin said it has received the USFDA's approval for Risperidone for extended-release injectable suspension
Analysts say Indian pharma firms will increase focus on non-US exports and the domestic market as US tariff threats persist, with firms exploring offshore manufacturing options
Pharma shares crash: In the past four weeks, the Nifty Pharma index has slipped 5 per cent, as against 0.19 per cent decline in the Nifty 50.
Fresh launches boosted growth for players like Lupin, Torrent
Lupin shares rose 5 per cent after the firm posted a 52 per cent year-on-year increase in net profit in Q1 FY26
Drug maker Lupin on Tuesday posted a 52 per cent year-on-year increase in consolidated profit after tax at Rs 1,221 crore in the June quarter, driven by strong sales in the US and India. The drug maker reported a profit after tax (PAT) of Rs 805 crore in the April-June quarter of last fiscal. Sales rose to Rs 6,164 crore in the first quarter as against Rs 5,514 crore in the year-ago period, Lupin Ltd said in a statement. "We continue to build strong business momentum, anchored by a robust product portfolio, improved efficiencies, and effective use of assets and investments," Lupin MD Nilesh Gupta said. "As we begin the year, our sharpened focus on compliance, innovation, and technology positions us to further unlock sustainable growth," he added. The company said its sales in the US stood at Rs 2,404 crore in the June quarter, registering a growth of 24 per cent as compared to Rs 1,934 crore in the year-ago period. India sales for Q1 FY26 stood at Rs 2,089 crore, up 8 per cent fr
Q1 FY26 company results, August 5: Britannia, Alembic Pharmaceuticals, Aarti Surfactants, Berger Paints, Bharti Hexacom, and Exide are also to release their April-June quarter earnings reports today
Trump on Wednesday called India's tariffs on US exports among the highest in the world, with the most strenuous non-monetary trade barriers of any country, in a post on Truth Social
Stocks to Watch today, July 18, 2025: Wipro, LTIMindtree, Lupin and IHCL are some of the key stocks to watch today
Lupin's share price rose today after the company announced the launch of Loteprednol Etabonate Ophthalmic Suspension, 0.5 per cent, in the US market.
Lupin's share price rose in trade today after the company announced a licensing and supply agreement with Zentiva, k.s., for the commercialisation of its biosimilar Certolizumab Pegol.
The product, launched in the US market, is a generic version of Atrovent and part of Lupin's plan to scale complex generics revenue share to 62 per cent by FY30
The carve-out will be effective from 1 July 2025, according to the company's regulatory filing on the exchanges.