Lupin receives USFDA approval for Rivaroxaban Tablets
Lupin announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Rivaroxaban Tablets USP, 10 mg, 15 mg, and 20 mg. Rivaroxaban Tablets are bioequivalent to Xarelto Tablets, 10 mg, 15 mg, and 20 mg, of Janssen Pharmaceuticals. This product will be manufactured at Lupin's Aurangabad facility in India.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Mint
2 days ago
- Mint
Stocks to buy: Lupin, Aurobindo, Max Healthcare among Axis Sec's top pharma & hospital picks post strong Q4
Stocks to buy: Axis Securities has reaffirmed its bullish view on the pharmaceuticals and hospital sectors in its latest report following the March quarter results, reiterating confidence in select stocks such as Lupin, Aurobindo Pharma, Max Healthcare, and Fortis Healthcare, citing emerging opportunities supported by strong fundamentals and favorable industry dynamics. The brokerage noted that the pharmaceuticals industry appears well-positioned for FY26 and beyond, supported by a strong product pipeline in biosimilars, GLP-1, and peptides. It highlighted that chronic therapies continue to outperform the overall Indian Pharmaceutical Market (IPM), contributing to sustained growth. Additionally, margins are expected to remain stable to improving, aided by a favorable product mix and easing input costs. The US generics business also shows continued strength, with leading players like Lupin and Aurobindo Pharma maintaining meaningful market shares despite ongoing competitive pressures and anticipated low single-digit price erosion. Stock Name Rating Latest closing price Target price Upside Potential Aurobindo Pharma Buy ₹ 1,138 ₹ 1,500 31.2% Lupin Buy ₹ 1,944 ₹ 2,500 28.6% Max Healthcare Institute Buy ₹ 1,147 ₹ 1315 15% Fortis Healthcare Buy ₹ 729 ₹ 775 6.3% Axis believes that companies with a differentiated portfolio and greater exposure to complex generics are likely to outperform in this environment. Consequently, it maintained 'buy' on Aurobindo Pharma and Lupin with a 'buy' rating and has a target price of ₹ 1,500 and ₹ 2500, respectively. In the hospital space, Axis Securities observed that the growth trajectory remains strong, backed by structural tailwinds. These include increased surgical volumes, an improved payer mix, and rising demand for high-growth therapies such as cancer and cardiac care—all of which are contributing to higher ARPOB (average revenue per occupied bed) and occupancy rates. The brokerage expects industry ARPOB to grow at 6–7% annually, with a 100-basis-point improvement in occupancy rates, supporting further margin expansion. Max Healthcare and Fortis Healthcare are viewed as well-positioned to benefit from these secular growth trends, given their scalable operations and strong execution across key metrics. Therefore, it retained a 'buy' recommendation on both the stocks, with a price target of ₹ 1,315 on Max Healthcare shares and ₹ 775 apiece on Fortis Healthcare shares. The pharmaceutical sector delivered a healthy performance in Q4FY25, with revenue growth of 12.3% YoY and 2.3% QoQ, driven primarily by the India business (11.2% YoY). The US generics business recorded 7.7% YoY growth in CC terms, aided by the launch of niche products and price stability. Improvement in gross margins to 66.1% (up 95 bps YoY) was underpinned by a favourable mix shift, muted price erosion, and stable input costs, said Axis Securities. In the hospital sector, revenue grew by 20% YoY and 2% QoQ, supported by higher occupancy rates (+60 bps YoY), an ARPOB increase of 6% YoY, and an 18% rise in operational bed days. Notably, the brokerage stated that the contribution of insurance payers rose to 33%, indicating deeper penetration and improved affordability. Disclaimer: The views and recommendations given in this article are those of individual analysts. These do not represent the views of Mint. We advise investors to check with certified experts before taking any investment decisions.
&w=3840&q=100)
Business Standard
3 days ago
- Business Standard
Gland Pharma share rises 2% in trade on Wednesday, June 4; here's why
Gland Pharma share price: Pharmaceutical company Gland Pharma shares increased as much as 1.58 per cent to hit an intraday high of 1,619 per share on Wednesday, June 4, 2025. At 11:10 AM, Gland Pharma shares continued to trade near day's high, up 1.33 per cent at 1615 per share. Why did Gland Pharma share price rise? Gland Pharma shares rose after it secured United States Food and Drug Administration (USFDA) approval for its Abbreviated New Drug Application (ANDA) for Angiotensin II Acetate Injection 2.5 mg/mL. 'Gland Pharma Limited (Gland or Company), a generic injectable & ophthalmicfocused pharmaceutical company, has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Angiotensin II Acetate Injection 2.5 mg/mL,' Gland Pharma said, in a press release. Angiotensin II is a vasoconstrictor indicated for increasing blood pressure in adults with septic or other distributive shock. The Product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Giapreza of La Jolla Pharma LLC, the company revealed. 'Gland Pharma is the exclusive First-to-File and is eligible for 180 days of generic drug exclusivity,' the company claimed. The product had US sales of approximately $58 million for the twelve months ending March 2025, according to IQVIA. Gland Pharma Q4 results Gland Pharma reported a 3 per cent year-on-year (YoY) decline in its consolidated net profit to ₹186.5 crore for the fourth quarter ended March 2025 (Q4FY25), compared to ₹192.4 crore in the same period last year. Revenue from operations fell 7 per cent YoY to ₹1,424.9 crore from ₹1,537.5 crore. The company's Ebitda stood at ₹347.5 crore, marginally down from ₹358.7 crore a year ago. However, the Ebitda margin improved to 24 per cent in Q4FY25, compared to 23 per cent in the corresponding quarter last year. Research and development (R&D) expenses during the quarter were ₹50.3 crore, accounting for 4.9 per cent of revenue. For the full financial year FY25, R&D expenses stood at ₹192.2 crore, or 4.7 per cent of annual revenue. Gland Pharma dividend About Gland Pharma Founded in 1978 in Hyderabad, Gland Pharma has evolved from a contract manufacturer of small-volume liquid parenterals to one of the largest injectable-focused pharmaceutical companies globally. Operating predominantly under a B2B model, it has a presence in over 60 countries, including the US, Europe, Canada, Australia, and India. The company's portfolio spans a wide range of sterile injectables such as vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions, as well as oncology and ophthalmic products. Notably, it pioneered Heparin technology in India.
Business Standard
3 days ago
- Business Standard
Gland Pharma gets US FDA approval for hypotension treatment drug Angiotensin II
Gland Pharma said that it has received approval from the United States Food and Drug Administration (US FDA) for its abbreviated new drug application (ANDA) for Angiotensin II Acetate Injection. The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD) GIAPREZA of La Jolla Pharma LLC. This product is indicated for increasing the blood pressure in adults with septic or other distributive shock. Gland Pharma is the exclusive first-to-file and is eligible for 180 days of generic drug exclusivity. According to IQVIA, the product had US sales of approximately $58 million for the twelve months ending March 2025. Gland Pharma is one of the largest and fastest-growing injectable-focused companies, with a global footprint across 60 countries, including the United States, Europe, Canada, Australia, India, and other markets. It has a wide range of injectables, including vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions, oncology, and ophthalmic solutions. The company also pioneered heparin technology in India. The company's consolidated net profit declined 3.06% to Rs 186.54 crore as net sales fell by 7.32% to Rs 1424.91 crore in Q4 FY25 as compared with Q4 FY24. The scrip rose 0.32% to currently trade at Rs 1598.95 on the BSE.
