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Granules India's Bonthapally facility completes US FDA inspection with one observation
Granules India's Bonthapally facility completes US FDA inspection with one observation

Business Upturn

timea day ago

  • Business
  • Business Upturn

Granules India's Bonthapally facility completes US FDA inspection with one observation

By Aditya Bhagchandani Published on June 20, 2025, 16:28 IST Granules India announced on June 20, 2025, that its API Unit-I facility at Bonthapally, located in Sangareddy District near Hyderabad, has successfully completed a US FDA inspection conducted between June 16 and June 20. The inspection concluded with a single Form 483 observation. In an exchange filing, the company stated it would address the observation within the prescribed timeline. Granules emphasized that the Bonthapally facility is one of the world's largest single-site Paracetamol API manufacturing units by volume and also houses manufacturing plants for Metformin and Guaifenesin APIs. The company assured investors that the outcome will be managed in line with regulatory expectations. 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. Ahmedabad Plane Crash Aditya Bhagchandani serves as the Senior Editor and Writer at Business Upturn, where he leads coverage across the Business, Finance, Corporate, and Stock Market segments. With a keen eye for detail and a commitment to journalistic integrity, he not only contributes insightful articles but also oversees editorial direction for the reporting team.

Paracetamol pills urgently recalled over contamination fears
Paracetamol pills urgently recalled over contamination fears

Wales Online

time09-06-2025

  • Health
  • Wales Online

Paracetamol pills urgently recalled over contamination fears

Paracetamol pills urgently recalled over contamination fears A statement issued by the Medicines and Healthcare products Regulatory Agency (MHRA) said Chelonia Healthcare Limited is recalling specific batches of Paracetamol 500mg Tablets (100 pots) An urgent recall has been issued for batches of paracetamol which could be contaminated (Image: Anton Petrus via Getty Images ) Patients have been urged to return certain batches of paracetamol due to contamination fears, according to an announcement made on Monday. The Medicines and Healthcare products Regulatory Agency (MHRA) said that Chelonia Healthcare Limited, the manufacturer, is recalling specific batches of paracetamol 500mg tablets (100 pots) as a precautionary measure, reports the Mirror. The urgent recall is reportedly "due to contamination following a small number of complaints of discoloured tablets within the pots" and an alert has been issued to anyone who has bought them. ‌ It advises: "Patients or carers should check to see if they have received tablets from the listed batches of Paracetamol 500 mg Tablets. The batch number can be found on the label of the medicine bottle and on the outer carton. ‌ "These tablets can only be obtained from a pharmacy with a prescription. The number of tablets you will have been given will vary depending on your prescription and you may have only received a small number of tablets." For the latest restaurant news and reviews, sign up to our food and drink newsletter here . Medicine Details: Paracetamol 500mg Tablets. Article continues below PL: 33414/0126. Active ingredient: Paracetamol. SNOMED code: 33554711000001108. ‌ GTIN: 05060014445506. The statement further added: "The tablets should be 'white capsule-shaped tablets, scored on one side', as per the Patient Information Leaflet (PIL). If you find tablets that are discoloured in any way, in pots from the listed batches, please contact your pharmacist or the healthcare professional who dispensed your prescription. "Patients who experience adverse reactions or have any questions about the medication, should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme." Article continues below The MHRA has classified the recall as Class 2, suggesting that while the defect could result in mistreatment or harm, it is not deemed life-threatening or serious. Pharmacists have been given explicit instructions: "Stop supplying the above batches immediately. Quarantine all remaining stock and return it to your supplier, using your supplier's approved process."

Common supplements and medications could cause liver damage, studies show
Common supplements and medications could cause liver damage, studies show

Yahoo

time02-06-2025

  • Business
  • Yahoo

Common supplements and medications could cause liver damage, studies show

As cases of drug-induced liver injury (DILI) are on the rise, experts are warning of the hidden dangers associated with some common medications and supplements. Statistics show that DILI, also known as toxic hepatitis or hepatotoxicity — which is known to be a significant cause of acute liver failure — has been growing in Western countries since the 1960s. Around one-fifth of the total population who are prescribed medications will experience DILI, according to recent research published in the journal Toxicology Reports. Common Daily Vitamin Could Slow Biological Aging, Major Study Suggests Potential triggers of liver injury include herbal products, dietary supplements and medications, the study found. Those with pre-existing liver conditions and nutritional deficiencies are at a higher risk, as are pregnant women. Read On The Fox News App One of the liver's main functions is to break down substances taken orally, including supplements and medications, according to the American College of Gastroenterology (ACG). For some people, the process of metabolizing these substances can be slower, increasing the risk of liver damage. Colorectal Cancer Risk Reduced By This Common Vitamin, Study Suggests Even medications that have been tested for safety and approved by the U.S. Food and Drug Administration (FDA) can potentially cause liver injury in rare cases, stated the ACG. Common symptoms of liver disease include nausea, loss of appetite, abdominal pain, generalized itching, dark urine and jaundice, although some people may notice no signs, per the above source. Alcohol Drives Up Liver Transplant Demand In Young People The recent study in Toxicology Reports identified several drugs that are most likely to cause liver injury. Paracetamol (acetaminophen), a common over-the-counter pain reliever Nonsteroidal anti-inflammatory drugs (NSAIDs), which are often used to treat headaches, fever and chronic inflammatory disorders Aspirin, a common over-the-counter medication used as a fever-reducer, pain reliever and blood thinner Nimesulide, an NSAID used to relieve pain and reduce fever Methotrexate, an antimetabolite medication that is used to treat rheumatoid arthritis, lymphoma, leukemia and other cancers Corticosteroids, which are used to treat conditions involving inflammation or overactive immune systems Isoniazid, a first-line treatment for tuberculosis Tetracyclines, a class of antibiotics that treat multiple types of bacterial infections Halothane, which is used as a general anaesthetic during surgical procedures Medications aren't the only agents that can cause drug-induced liver injuries. Dr. Marc Siegel, Fox News senior medical analyst, spoke with Fox News Digital about the risks of herbal and dietary supplements (HDS) affecting the liver. "The biggest problem with herbal supplements is that the amount you are taking of active chemicals isn't strictly regulated, so you don't know exactly what you are getting," he said. "And since several of the supplements are metabolized through the liver, there is now an increasing incidence of liver toxicity in users." Cases of DILI linked to herbal or dietary supplements have nearly tripled between 2004 and 2014, according to a 2024 study published in JAMA Network Open. The researchers identified the following most commonly used botanical products known for potential liver toxicity. Turmeric, a common spice added to foods Green tea Ashwagandha, an herb used for stress and anxiety Garcinia cambogia, a popular weight-loss supplement Red yeast rice, which is said to help lower cholesterol levels Black cohosh, a dietary supplement used to relieve menopause symptoms It is estimated that at least 15.6 million U.S. adults have used at least one of these six botanical products within the past 30 days. Common Supplement Could Help You Live Longer, Research Suggests "The most commonly implicated botanical products in the DILIN (Drug-Induced Liver Injury Network) include turmeric, kratom, green tea extract and Garcinia cambogia, with potentially severe and even fatal liver injury," the study stated. Drug-induced liver injury caused by HDS can be severe or even fatal, leading to death or liver transplantation, the researchers noted. Fox News' Siegel also warned against the potential liver-related risks of some of these named supplements. "Turmeric is a natural anti-inflammatory and may be useful in small doses, but can be toxic in large doses," he cautioned. "Garcinia cambogia is very popular, especially as a weight-loss agent, but there is no real evidence that it actually works, and there is no reason to take it, especially with the new GLP-1 drugs." While red yeast rice has cholesterol-lowering statin-type properties, Siegel cautioned that the amount of active chemicals isn't as strictly regulated as approved medications. "I find it useful in some patients who are reluctant to start statins and are looking for a more natural alternative, but I must strictly monitor the amount taken and the effect on the liver," he said. Regarding green tea, Siegel noted that it does have antioxidant properties and can be useful to consume as a beverage (though it has a lot of caffeine) — "but there is no reason whatsoever to take more of it in an extract, where it can be toxic." Click Here To Sign Up For Our Health Newsletter The FDA states on its website that it does regulate dietary supplement products and dietary ingredients, but under "a different set of regulations than those covering 'conventional' foods and drug products." "Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded," the agency says. "That means that these firms are responsible for evaluating the safety and labeling of their products before marketing to ensure that they meet all the requirements of the Federal Food, Drug, and Cosmetic Act as amended by DSHEA and FDA regulations." For more Health articles, visit Fox News Digital reached out to several researchers and the FDA regarding the rise in drug- and HSD-related liver article source: Common supplements and medications could cause liver damage, studies show

Powerful earthquake in Myanmar has to date killed 3,728 people, injured 5,104, and left 79 people missing
Powerful earthquake in Myanmar has to date killed 3,728 people, injured 5,104, and left 79 people missing

The Star

time20-05-2025

  • Health
  • The Star

Powerful earthquake in Myanmar has to date killed 3,728 people, injured 5,104, and left 79 people missing

YANGON: As of Monday (May 19), the extremely strong earthquake that struck Myanmar on March 28 has killed 3,728 people, injured 5,104, and left 79 people missing in the six regions/states that were severely affected. Myanmar Fire Brigade and search and rescue teams from home and abroad are conducting timely search and rescue operations in the areas where they are needed. As of Monday, 653 survivors have been rescued and 805 dead have been recovered. Local volunteers are donating money and goods to the affected people, as well as foreign countries, organisations, and volunteers. On May 16, 20 bags of Paracetamol (weighing 0.285 tons) were donated by the Embassy of India and on May 19, 19 bags of ointments and household medicines (weighing 0.279 tons) donated by the Embassy of India arrived at Yangon International Airport. The medicines and goods donated by India will be transferred to the Ministry of Health for use in healthcare activities. - Eleven Media/ANN

Chemists' org warns against Centre's plan to expand OTC drug list
Chemists' org warns against Centre's plan to expand OTC drug list

Time of India

time17-05-2025

  • Health
  • Time of India

Chemists' org warns against Centre's plan to expand OTC drug list

1 2 Shillong: The All India Organisation of Chemists and Druggists has cautioned against the Centre's proposal to classify more medicines as over-the-counter (OTC) products, maintaining that this would have harmful effects on the health of the people. In a statement issued on Friday, the Meghalaya Healthcare Association , which is a unit of the AIOCD, cautioned the potentially dangerous consequences of this move and pointed out that medicines, even those used routinely, require expert supervision to avoid harmful effects. "Paracetamol is widely used as a pain reliever, but an overdose can cause serious liver and kidney damage," David Kharsati, president of the Association said in the statement and also highlighted the risks of diclofenac, a common anti-inflammatory drug available in potassium and sodium forms. "These two variants must be prescribed carefully, especially for patients with blood pressure issues. Interchanging them without proper guidance can worsen the condition," he said. He added while the govt may aim to simplify access, expanding the OTC list could disrupt the existing supply chain and lead to confusion among consumers. The AIOCD, which represents around 12.5 lakh chemists across India, also raised concerns about the growing financial strain on local pharmacies and cited the rise of online pharmacies and govt-supported schemes like Jan Aushadhi and Dawa India as major factors behind declining business margins.

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