Latest news with #UnitedStatesFoodandDrugAdministration
Business Standard
23 minutes ago
- Business
- Business Standard
Cipla's Bengaluru facility gets one USFDA observation
Cipla announced that the United States Food and Drug Administration (USFDA) has concluded a current Good Manufacturing Practices (cGMP) inspection at its manufacturing facility in Bommasandra, Bengaluru. According to a regulatory filing, the inspection was carried out from 26 May 2025 to 30 May 2025. At the conclusion of the inspection, the USFDA issued one observation in Form 483. The company stated that it will work closely with the USFDA and remains committed to addressing the observation comprehensively within the stipulated timeframe. In Q4 FY25, Cipla reported a 30.1% year-on-year increase in consolidated net profit to Rs 1,222 crore, while total income rose 9.2% to Rs 6,730 crore. Cipla is a global pharmaceutical company focused on agile and sustainable growth, complex generics, and deepening portfolios in our home markets of India, South Africa, North America, and key regulated and emerging markets. The scrip shed 0.19% to currently trade at Rs 1,462 on the BSE.
Business Upturn
23 minutes ago
- Business
- Business Upturn
Alembic Pharma shares dip over 2% after USFDA issues 4 observations for Panelav facility
By Aman Shukla Published on June 2, 2025, 10:25 IST Shares of Alembic Pharmaceuticals fell over 2% on Monday following news that the United States Food and Drug Administration (USFDA) issued four observations after inspecting the company's API-I & II facility at Panelav, Gujarat. As of 10:22 AM, the shares were trading 1.88% lower at Rs 998.90. The unannounced, routine cGMP (current Good Manufacturing Practices) inspection was conducted between May 26 and May 31, 2025. At the conclusion of the inspection, the USFDA issued a Form 483 outlining four observations. Importantly, Alembic confirmed that none of the observations relate to data integrity — a key concern for regulators and investors. The company stated that it will submit a comprehensive response to the USFDA within the required timeframe. Management emphasized that the issues raised are 'addressable' and reiterated its commitment to maintaining high standards of quality and regulatory compliance. Disclaimer: The information provided is for informational purposes only and should not be considered financial or investment advice. Stock market investments are subject to market risks. Always conduct your own research or consult a financial advisor before making investment decisions. Author or Business Upturn is not liable for any losses arising from the use of this information. Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at
Business Upturn
4 hours ago
- Business
- Business Upturn
Zydus receives tentative USFDA approval for Rifaximin Tablets, 550 mg
By Aman Shukla Published on June 2, 2025, 08:12 IST Zydus Lifesciences Limited, along with its subsidiaries and affiliates (collectively referred to as 'Zydus'), has received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Rifaximin Tablets, 550 mg. The approved product is a generic version of Xifaxan® Tablets, 550 mg, which is indicated for the treatment of irritable bowel syndrome with diarrhoea (IBS-D) in adults. The tablets will be manufactured at the company's SEZ II facility in Ahmedabad, India. According to IQVIA MAT data for March 2025, Rifaximin Tablets, 550 mg, recorded annual sales of approximately USD $2,672.9 million in the U.S. market. With this tentative approval, Zydus now has a total of 427 ANDA approvals. Since beginning its ANDA filings in the financial year 2003–04, the company has submitted 492 ANDAs to date. Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at
NDTV
3 days ago
- Health
- NDTV
Why Cucumber Juice Should Be Your Summer Secret To Easy Weight Loss
Show Quick Read Summary is AI-generated, newsroom-reviewed When the summer heat starts making you feel sluggish, nothing beats sipping something cool and refreshing. Thanks to the season's bounty of fruits and vegetables, summer offers plenty of healthy options. One of the most popular and tasty choices is cucumber juice. Not only is it delicious, but it also helps you shed those stubborn kilos. It is not just another detox trend flooding Instagram; cucumber juice genuinely benefits your body. If you want a healthier alternative to sugary summer drinks, this is it. Best part? It is affordable, weight-loss-friendly, and requires zero fancy preparation. Just blend and sip! Here is how adding cucumber juice to your daily routine might help you achieve that summer body you want. Here Are 5 Ways Cucumber Juice Supports Weight Loss And Hydration: 1. Keeps You Hydrated Hydration is often overlooked in weight loss. Research from the Web of Science shows cucumber is about 95 per cent water. Drinking cucumber juice quenches your thirst and supports your body's natural detox. Dehydration causes your body to hold on to water, making you feel bloated and puffy. So, drink cucumber juice to stay hydrated and keep your weight in check. 2. Low In Calories, High In Satisfaction No one wants to starve on a diet. According to the United States Food and Drug Administration, 99 grams of cucumber has just 10 calories. Yes, just 10! Plus, its volume helps you feel full longer. When your stomach feels satisfied, you are less tempted to reach for chips or fried snacks after lunch. 3. Reduces Bloating And Water Retention Water retention and bloating often happen when you eat salty or processed food without enough fluids. Cucumber juice, with its high-water content, helps flush out toxins. Its mild diuretic properties remove extra water and sodium, reducing puffiness around your face and belly. It is also gentle on your stomach, helping your digestion stay smooth. 4. Detoxifies With Antioxidants And Anti-Inflammatory Compounds Cucumber juice is packed with antioxidants, vitamin K, and compounds called cucurbitacins. For those who are not familiar, cucurbitacins have been shown to fight inflammation and diabetes, according to research from the National Institutes of Health. Clearing inflammation and toxins helps your metabolism run better, which supports weight loss. 5. Keeps You Feeling Light And Energised Heavy snacks can leave you sluggish, but cucumber juice does the opposite. It cools and refreshes, making it a perfect summer drink for weight loss. Loaded with natural electrolytes like potassium and magnesium, it balances your body fluids and keeps fatigue away. This makes it a great drink before or after a workout - light on the stomach, hydrating, and helpful in managing weight. So, if you want to shed those extra kilos without drama, make cucumber juice your summer go-to.
Business Upturn
5 days ago
- Health
- Business Upturn
Zydus receives USFDA Fast Track Designation for Usnoflast in the treatment of ALS
By Aman Shukla Published on May 28, 2025, 11:14 IST Zydus, a discovery-driven global pharmaceutical company, has announced that the United States Food and Drug Administration (USFDA) has granted Fast Track Designation to its investigational drug, Usnoflast, for the treatment of amyotrophic lateral sclerosis (ALS). This designation is intended to expedite the development and review of drugs that address serious conditions and fill an unmet medical need. It allows for more frequent communication with the FDA and makes the drug eligible for accelerated approval and priority review, provided certain criteria are met. ALS is a progressive neurodegenerative disease that primarily affects motor neurons. Patients with ALS typically experience muscle weakness, loss of motor control, difficulty speaking and swallowing, and ultimately respiratory failure. The average life expectancy following diagnosis ranges from two to five years. Neuroinflammation and axonal degeneration are key features of the disease, contributing to the buildup of neurofilaments in cerebrospinal fluid and, eventually, in the bloodstream. This process is linked to the rapid progression and severe impact of ALS on physical function and quality of life. Usnoflast, also known as ZYIL1, is an oral small molecule that targets the NLRP3 inflammasome pathway, which is believed to play a role in neuroinflammatory diseases. The drug has shown promise in pre-clinical studies involving models of neuroinflammation, Parkinson's disease, Inflammatory Bowel Disease (IBD), and Multiple Sclerosis (MS). In India, Zydus completed a Phase 2(a) randomized, double-blind, placebo-controlled trial of Usnoflast in 24 ALS patients across seven clinical trial sites. The study is registered under the Identifier NCT05981040. Building on this research, Zydus has received USFDA approval to begin a Phase 2(b) clinical trial in the United States. This upcoming study will also be randomized, double-blind, and placebo-controlled, further evaluating the potential of Usnoflast as a treatment option for ALS. ALS affects an estimated 32,000 individuals in the U.S., with approximately 5,000 new cases diagnosed each year. In Europe, more than 30,000 people are believed to be living with the condition, and in India, the number is estimated to be around 75,000. Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at
