logo
Alembic Pharmaceuticals receives USFDA approval for Rivaroxaban Tablets

Alembic Pharmaceuticals receives USFDA approval for Rivaroxaban Tablets

Alembic Pharmaceuticals (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Rivaroxaban Tablets USP, 2.5 mg, 10 mg, 15 mg, and 20 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Xarelto Tablets, 2.5 mg, 10 mg, 15 mg, and 20 mg, of Janssen Pharmaceuticals, Inc. (Janssen).
Rivaroxaban tablets, 2.5mg, are indicated: i) to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD), ii) to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD. Refer label for a detailed indication.
According to IQVIA, Rivaroxaban Tablets USP, 2.5 mg, has an estimated market size of US$ 445 million for twelve months ending March 2025 and Alembic will be launching this strength in Q1FY26.
The estimated market size for remaining strengths of Rivaroxaban Tablets USP, 10 mg, 15 mg, and 20 mg, is US$ 8,052 million for twelve months ending March 2025 according to IQVIA.
Orange background

Try Our AI Features

Explore what Daily8 AI can do for you:

Comments

No comments yet...

Related Articles

FPI selloff: Rs 21,000 crore offloaded from Indian markets in August first half; Analysts cite US tariffs, Q1 earnings and rupee depreciation
FPI selloff: Rs 21,000 crore offloaded from Indian markets in August first half; Analysts cite US tariffs, Q1 earnings and rupee depreciation

Time of India

time42 minutes ago

  • Time of India

FPI selloff: Rs 21,000 crore offloaded from Indian markets in August first half; Analysts cite US tariffs, Q1 earnings and rupee depreciation

Foreign portfolio investors offloaded Indian equity holdings by approximately Rs 21,000 crore in early August 2025, driven by US-India trade disputes, muted Q1 corporate results, and rupee depreciation. The total FPI equity outflows reached Rs 1.16 lakh crore in 2025, as per depository records. Meanwhile, depository data also show that FPIs withdrew Rs 20,975 crore from equities through August 14. This follows July's Rs 17,741 crore withdrawal, which contrasts with the Rs 38,673 crore investment during March to June. The reduced US-Russia tensions and absence of new sanctions indicate that the proposed 25 per cent secondary tariff on India might not be implemented after August 27, benefiting markets, according to Vaqarjaved Khan, CFA - Senior Fundamental Analyst, Angel One, as quoted by PTI. S&P's upgrade of India's credit rating from BBB- to BBB could positively influence FPI outlook, he further noted. "The sustained outflows are being driven primarily by a confluence of global uncertainties. Heightened geopolitical tensions and ambiguity surrounding the interest rate trajectory in developed economies, particularly the United States, have contributed to a risk-averse sentiment," stated Himanshu Srivastava, Associate Director - Manager Research, Morningstar Investment Research India. Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Could This NEW Collagen Blend Finally Reduce Your Cellulite? Vitauthority Learn More Undo by Taboola by Taboola The strengthening US dollar has reduced emerging market investments' appeal, including India's, he explained. VK Vijayakumar, Chief Investment Strategist, Geojit Investments, attributed the outflows to modest earnings growth and high valuations. Continuous selling affected IT sector performance, while banking and financial sectors remained stable due to reasonable valuations and institutional investment. Conversely, FPIs invested Rs 4,469 crore in debt general limits and Rs 232 crore through the voluntary retention route during this period. Stay informed with the latest business news, updates on bank holidays , public holidays , current gold rate and silver price .

Output growth forecast for Taiwan semiconductors increased
Output growth forecast for Taiwan semiconductors increased

Mint

time2 hours ago

  • Mint

Output growth forecast for Taiwan semiconductors increased

Taipei [Taiwan], August 17 (ANI): Taiwan's government-supported Industrial Technology Research Institute (ITRI) has raised its forecast for 2025 growth in the output value of the country's semiconductor industry to above 22 per cent on strong global demand for artificial intelligence applications, Focus Taiwan reported. In its latest IEK Current Quarterly Model report, the ITRI said the local semiconductor industry will have output of NT$6.5 trillion (US$216.67 billion) in 2025, up 22.2 per cent from a year earlier, an upward revision from a 19.1 per cent increase estimate made in May. The ITRI said the strong showing of the local semiconductor industry largely reflected the stronger-than-expected performance of the IC manufacturing segment. The ITRI forecast came after Taiwan Semiconductor Manufacturing Co. (TSMC), the world's largest contract chipmaker, raised its forecast of sales growth to 30 per cent in 2025 from a previous estimate of 24-26 per cent. According to the Focus Taiwan report, TSMC attributed the higher guidance to the greater computing power needed for emerging AI applications, which has driven higher global demand for advanced chips. According to the ITRI, the IC manufacturing sector will generate NT$4.36 trillion in output in 2025, up 27.5 per cent from a year earlier, compared with an earlier estimate of a 23.1 per cent increase. The output value of the pure foundry wafer business, where TSMC has taken the lead over its peers globally, is expected to reach NT$4.16 trillion, up 28.3 per cent from a year earlier, the ITRI said, as per the report. In 2025, the IC packaging segment is expected to see its output rising 13.5 per cent from a year earlier to NT$480.3 billion, while the IC testing segment is expected to post NT$230.5 billion in output, up 15.2 per cent from a year earlier, the news report cited the ITRI report. The IC design segment is expected to grow 12.1 per cent in 2025 to an output value of NT$1.42 trillion, and down from 13.9 per cent growth previously estimated, the ITRI said. In the second quarter, Taiwan's semiconductor industry posted an output value of NT$1.6 trillion, up 7.4 per cent from a quarter earlier. The IC manufacturing segment was the best performer in the industry, with NT$1.06 trillion in output, up 10.4 per cent from a quarter earlier, the ITRI said. The institute said the production value of the local semiconductor industry is expected to rise to about NT$1.68 trillion in the third quarter, up 4.8 per cent from a quarter earlier, while the output of the IC manufacturing segment is forecast to hit NT$1.15 trillion, up 7.3 per cent from the second quarter. (ANI)

Output growth forecast for Taiwan semiconductors increased
Output growth forecast for Taiwan semiconductors increased

Economic Times

time2 hours ago

  • Economic Times

Output growth forecast for Taiwan semiconductors increased

Agencies Taiwan's government-supported Industrial Technology Research Institute (ITRI) has raised its forecast for 2025 growth in the output value of the country's semiconductor industry to above 22% on strong global demand for artificial intelligence applications, Focus Taiwan reported. In its latest IEK Current Quarterly Model report, the ITRI said the local semiconductor industry will have output of NT$6.5 trillion (US $216.67 billion) in 2025, up 22.2% from a year earlier, an upward revision from a 19.1% increase estimate made in May. The ITRI said the strong showing of the local semiconductor industry largely reflected the stronger-than-expected performance of the IC manufacturing segment. The ITRI forecast came after Taiwan Semiconductor Manufacturing (TSMC), the world's largest contract chipmaker, raised its forecast of sales growth to 30% in 2025 from a previous estimate of 24-26%.According to the Focus Taiwan report, TSMC attributed the higher guidance to the greater computing power needed for emerging AI applications, which has driven higher global demand for advanced to the ITRI, the IC manufacturing sector will generate NT$4.36 trillion in output in 2025, up 27.5% from a year earlier, compared with an earlier estimate of a 23.1% output value of the pure foundry wafer business, where TSMC has taken the lead over its peers globally, is expected to reach NT$4.16 trillion, up 28.3% from a year earlier, the ITRI said, as per the report. In 2025, the IC packaging segment is expected to see its output rising 13.5% from a year earlier to NT$480.3 billion, while the IC testing segment is expected to post NT$230.5 billion in output, up 15.2% from a year earlier, the news report cited the ITRI report. The IC design segment is expected to grow 12.1% in 2025 to an output value of NT$1.42 trillion, and down from 13.9% growth previously estimated, the ITRI the second quarter, Taiwan's semiconductor industry posted an output value of NT$1.6 trillion, up 7.4% from a quarter IC manufacturing segment was the best performer in the industry, with NT$1.06 trillion in output, up 10.4% from a quarter earlier, the ITRI institute said the production value of the local semiconductor industry is expected to rise to about NT$1.68 trillion in the third quarter, up 4.8% from a quarter earlier, while the output of the IC manufacturing segment is forecast to hit NT$1.15 trillion, up 7.3% from the second quarter. Elevate your knowledge and leadership skills at a cost cheaper than your daily tea. Tariffs, tantrums, and tech: How Trump's trade drama is keeping Indian IT on tenterhooks How IDBI banker landed plush Delhi properties in Amtek's INR33k crore skimming Good, bad, ugly: How will higher ethanol in petrol play out for you? As big fat Indian wedding slims to budget, Manyavar loses lustre Regulatory gray area makes investing in LVMH, BP tough For Indian retail Logistics sector: Be tactical in the face of head & tailwinds; 6 logistics stocks with an upside potential of over 30% Just hold a good business for the long term, irrespective of the noise; ignore the cap. 13 stocks with an upside potential of up to 51% Stock picks of the week: 5 stocks with consistent score improvement and return potential of more than 25% in 1 year

DOWNLOAD THE APP

Get Started Now: Download the App

Ready to dive into a world of global content with local flavor? Download Daily8 app today from your preferred app store and start exploring.
app-storeplay-store