Zydus gets U.S. FDA tentative nod for Rifaximin tablets 550 mg

Generic drugmaker Zydus Lifesciences has received tentative approval from the U.S. Food and Drug Administration (FDA) for Rifaximin Tablets, 550 mg. The product is indicated for treatment of irritable bowel syndrome with diarrhoea (IBS-D) in adults. Rifaximin tablets had annual sales of $2672.9 million in the United States, the company said citing IQVIA MAT March 2025 numbers. The product will be produced at the Group's manufacturing site at SEZ II, Ahmedabad, it said on Monday.

Try Our AI Features

Explore what Daily8 AI can do for you:

Learn with AIFact CheckingText to SpeechAI Summary

Related Articles

Economic Times

35 minutes ago

• Economic Times

Granules India shares in focus after US FDA flags observation at Telangana API facility

Shares of Granules India will be in focus on Monday after the company announced that its active pharmaceutical ingredient (API) facility in Telangana has received an observation from the US Food and Drug Administration (FDA) under Form 483. ADVERTISEMENT In a stock exchange filing, Granules India said the FDA completed an inspection at its API Unit-1 facility in Bonthapally, Sangareddy district, last week. Also Read: 11 Nifty mid & smallcap stocks that can rally 40-90% over the next 12 months According to the FDA, Form 483 observations are issued when investigators observe practices or conditions that may potentially violate the Food, Drug and Cosmetic Act. However, a Form 483 does not constitute a final determination of non-compliance by the India said it will respond to the observation within the stipulated Bonthapally site is Granules India's largest API manufacturing facility for paracetamol. It also houses production units for Metformin and Guaifenesin APIs, the company said. ADVERTISEMENT Also Read: Is the grey market premium misleading? Decoding the valuation gap in HDB Financial's IPO ADVERTISEMENT According to Trendlyne, the average analyst target price for Granules India is Rs 622, indicating an upside potential of about 28% from current levels. Of the 8 analysts tracking the stock, the consensus rating is 'Strong Buy'.On the technical front, the Relative Strength Index (RSI) stands at 40.4, suggesting neutral to slightly bearish momentum. The stock continues to trade below its 20-day, 50-day, 100-day, and 200-day simple moving averages (SMAs), indicating continued pressure. ADVERTISEMENT Granules India shares have declined around 19% year-to-date, but the stock has delivered a 66% return over the past two years. The company's market capitalisation currently stands at approximately Rs 11,808 crore. Also Read: US strikes on Iran may rattle markets: Will Nifty, Sensex react to escalating geopolitical risk? (Disclaimer: Recommendations, suggestions, views, and opinions given by the experts are their own. These do not represent the views of Economic Times) (You can now subscribe to our ETMarkets WhatsApp channel)

Time of India

36 minutes ago

• Time of India

Midcaps, Smallcaps, and IT appear overheated as valuations stretch, says Ram Medury, Maxiom Wealth

After a sharp rally in Indian equities, concerns are mounting over stretched valuations in certain pockets of the market. In this edition of ETMarkets Smart Talk , Ram Medury , Founder and CEO of Maxiom Wealth , shares his cautious view on midcaps, smallcaps, and the IT sector, which he believes are beginning to look overheated. While the broader market outlook remains constructive for the second half of 2025, Medury advises investors to tread carefully in segments that have run up too fast, too soon. He also offers insights into sectoral opportunities, asset allocation post the RBI 's rate cut, and the impact of global geopolitical and trade risks on Indian equities. Edited Excerpts – Q) Thanks for taking the time out. June is turning out to be a volatile month for D-Street. How is 2H2025 likely to pan out for Indian markets? Do you think most of the negatives are behind us? by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Elegant New Scooters For Seniors In 2024: The Prices May Surprise You Mobility Scooter | Search Ads Learn More Undo A) We expect good rainfall in the upcoming monsoon period which may increase the earnings of 10-15% for agriculture-based stocks and also will help in reducing inflation at the base level. With the recent RBI rate cuts we assume a stable low inflation outlook but the global geopolitical scenario has changed quickly. As a large part of India's inflation is linked with crude oil we do have at least one negative ahead of us as oil price climbs. Overall, with increased spending on Infra by the government, the growth rate of the organised sector is expected to improve in H2. Live Events Q) What does a 50 bps cut mean for equity and bond markets? What should be an asset allocation strategy? A) A 50 bps rate cut by the RBI makes borrowing cheaper, boosting liquidity and supporting growth, which is positive for both equity and bond markets. In the current Indian scenario, rate-sensitive sectors like banks, autos, and real estate may see strong equity gains, while long-duration bonds are likely to rally as yields fall. Post the rate cut, Investors can consider increasing exposure to good quality stocks and on the fixed income side in Short duration/Accrual funds. A small allocation to gold can act as a hedge against potential inflation post recent geopolitical events. Q) What is your take on Q4 earnings from India Inc.? Any hits and misses which you tracked in the results? A) In the quarter ending Mar'25, YoY sales growth held steady near 9%, reflecting sustained business momentum. However, YoY PAT growth dropped to around 10% from nearly 17% in the previous quarter which can be counted as a 'miss'. Aggregate profit margins improved to 10%, returning to their recent peak. This would be a 'hit' as the trend continued for two consecutive quarters, indicating better operational efficiency in corporate India given the backdrop that both sales and profit growth receded from the prior quarter. Q) Nifty Bank hit a record high in June which suggests that there is a lot of interest in banking stocks. What is fuelling the rally in financials – is it the rate cut by RBI? A) The rate cut of RBI by 50 bps and CRR cut of 100 bps is expected to unlock 2.5 lakh crore for banks by Dec 25. This extra liquidity will help the banks in more disbursal and thereby improving their bottom-line and topline. The recent corrective measures by RBI to monitor MFI and unsecured lending as also result in lowering of distressed assets in big financial institutions which has also improved the overall health of banks' Balance Sheets. Q) Which sectors are likely to remain in limelight in the 2H2025? A) Banks and NBFCs would do well as a direct impact of the rate cut. The consumer durables sector is also expected to have a good run with increasing disposable income and increasing exports. With many of the consumer durables now working with MNCs to manufacture their products, there is room for growth in this sector. Defence is another sector that would do well given the geopolitical turbulence. Q) The tonality keeps changing from the US when it comes to 'Trade Talks'. Do you think it is still a relevant headwind for equity markets across the globe? A) The markets seem to be now shrugging off the initial apprehensions of tariff tantrums. US markets initially plunged after the new tariffs were announced in April 2025, with the S&P 500 falling nearly 15% at its lowest point. After a pause in tariff escalation and some policy walk-backs, markets rebounded, and the S&P 500 and Nasdaq are now modestly above where they started the year, while the Dow Jones remains slightly negative year-to-date. Despite the recovery, as of mid-June 2025, US markets have not fully regained their pre-tariff highs and remain volatile due to ongoing trade tensions and global uncertainties. Meanwhile, Indian markets have significantly outperformed US indices in the same period, reaching new highs and showing resilience despite global trade tensions and the US tariff shock. India has low trade exposure with the US if we consider direct import and export. But with the US tariff risk, comes global tariff risk which may impact the demand of Indian goods outside as competition intensifies. With the India US trade deal in talks and major new announcements coming up, we can expect India to be a beneficiary in few of the sectors like Auto Ancillaries and Electronics. Q) China equity markets are up in double digits while we have underperformed most EM peers. Does it make a case for global diversification? A) China's economy is growing at 5.4% but facing demographic and regulatory headwinds. While it holds strategic power in rare earths and currency innovation, export models are under strain. Its market remains undervalued, needing global trust to re-rate. Challenges loom, but scale and influence remain formidable on the world stage. Also, there is a lot of geopolitical tension all over the world, with three international borders on the boil, a lot of volatility is expected in all the major economies. Q) Which sector(s) is/are looking overheated and why? A) India's stock market rally has been broad-based, but concerns of overheating are rising in midcaps, smallcaps, IT and cyclical sectors like realty and metals. Valuations are appearing stretched, especially in mid and smallcaps, driven by strong retail inflows. IT is facing global demand and macroeconomic headwinds. The automobile sector, especially OEMs could be subdued this year, as the growth rate may be slower due to the high base last year. Despite gains, realty and metal sectors remain vulnerable to interest rate or commodity price shifts.

Mint

a day ago

• Mint

FDA recall alert: Chocolate products across the US recalled urgently by Weaver Nut Company, all you need to know

The Weaver Nut Company has suddenly recalled all its semi-sweet chocolate nonpareils with white or Christmas-colored seeds, with specific lot codes, that have been distributed throughout the United States. The reason for the recall has been cited as the presence of potential undeclared milk allergens, according to a recent press release issued by the U.S. Food and Drug Administration (FDA) on Wednesday. Company Announcement Date: June 17, 2025 FDA Publish Date: June 18, 2025 Product Type: Food & Beverages Allergens Reason for Announcement: Undeclared milk allergen Company Name: Weaver Nut Company Brand Name: Weaver Nut Company Product Description: Semi-sweet chocolate pareils with white or Christmas colored seeds The company announcement, as published by the FDA in the press release, reads, "Weaver Nut Company, Inc. is recalling the following chocolate products with specific lot codes, due to potential undeclared milk allergens. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reactions if they consume the impacted products and Lot's listed below." Item / Description: 47518 - Nonpareil, Semi-Sweet Chocolate (Christmas Seeds) with Lot numbers: 204206, 204207, 204208, 204209, 204212, 224225 Item / Description: D2645 - Nonpareils, Semi-Sweet Chocolate (White Seeds) with Lot numbers: 204214-RL, 204214, 204215, 224221, 224222, 224223, 135215, 135216, 135217, 135220, 135221, 145204, 145205-1, 145207-1, 145210-1