Page 5 - Glenmark Pharmaceuticals

Cipla, Glenmark recall drugs from US over manufacturing issues: USFDA

Drug makers Cipla and Glenmark are recalling products from the American market due to manufacturing issues, according to the US health regulator. As per the latest Enforcement Report issued by the US Food and Drug Administration (USFDA), a New Jersey-based subsidiary of Cipla is recalling 59,244 packs of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution. The medication, produced at the company's Indore SEZ plant, is used to help control the symptoms of lung diseases, such as asthma, chronic bronchitis and emphysema. Cipla USA is recalling the affected lot due to "short fill". There were complaints of less fill volume in respule and few drops of liquid observed in the intact pouch, USFDA said. Cipla initiated the Class II recall in the US market on March 26 this year. USFDA also said that Glenmark Pharma is recalling 3,264 bottles of Diltiazem Hydrochloride extended-release capsules indicated for high blood pressure. The US-based arm of the company -- Glenmark ...

Glenmark Pharma receives USFDA nod for generic anti-inflammatory drug

Glenmark Pharmaceuticals on Monday said it has received approval from the US health regulator to sell a generic version of anti-inflammatory drug in the American market. The company has received approval from the US Food and Drug Administration (USFDA) for Acetaminophen and Ibuprofen tablets (250 mg/125 mg), the Mumbai-based drug maker said in a statement. The company's product is the generic version of Haleon US Holdings, LLC's Advil 2 Dual Action with Acetaminophen Tablets, 250 mg/125 mg (OTC), it added. Glenmark Therapeutics Inc, USA will distribute the drug in the US market, the drug maker said. According to Nielsen syndicated data for the latest 52 weeks period ending March 23, 2024, the Advil Dual Action with Acetaminophen Tablets, 250 mg/125 mg achieved annual sales of around USD 84.1 million. Glenmark said its current portfolio consists of 195 products authorised for distribution in the US marketplace and 52 abbreviated new drug applications (ANDAs) pending approval with

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Technical outlook on stocks with high rollover to May series: Keep a tab on these key support and resistance levels while trading in these F&O stocks.

Glenmark Life Sciences Q4 results: Profit down 33% at Rs 97.9 crore

Revenue from its API business, its biggest, fell 8.6% in the fourth quarter, leading to a nearly 14% fall in its total revenue

Glenmark Pharma recalls 6,528 bottles of blood pressure drug in US

Glenmark Pharmaceuticals is recalling 6,528 bottles of a medication used to treat high blood pressure in the American market due to failed dissolution specifications, the US health regulator said. The US-based arm of the Mumbai-headquartered drug firm is recalling the affected lot of Diltiazem Hydrochloride extended-release capsules, the US Food and Drug Administration said in its latest Enforcement Report. The affected lot has been produced in India and is being recalled by New Jersey-based Glenmark Pharmaceuticals Inc for "failed dissolution specifications", the USFDA said. "Out of Specification (OOS) was reported in a test of dissolution at the 12th month time point in long-term stability study," it noted. Glenmark initiated Class II recall of the drug across the US on March 26 this year. As per the USFDA, a Class II recall is initiated in a situation in which the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences

Glenn Saldanha announced resignation as chairman of Glenmark Life Sciences

Glenmark Life Sciences Ltd on Wednesday said its Chairman Glenn Saldanha and non-executive director VS Mani have resigned following change in ownership of the company. Independent director Sridhar Gorthi has also tendered resignation, along with Saldanha and Mani, with effect from close of business hours on March 6, 2024, the company said in a regulatory filing. In his resignation letter shared on BSE by the company, Saldanha said his stepping down from the board and as chairman of the company is "pursuant to the transfer of ownership of the company by Glenmark Pharmaceuticals to Nirma Ltd". He is also stepping down as a member of the nomination and remuneration committee and operations committee of Glenmark Life Sciences. In September last year, Nirma Ltd had agreed to acquire 75 per cent stake in Glenmark Life Sciences for Rs 5,651.5 crore from Glenmark Pharmaceuticals. Mani also cited a similar reason for his resignation. On the other hand, Gorthi cited increasing professiona

Glenmark Pharma eyes $80 mn from it's nasal spray Ryaltris sales next year

Glenmark Pharmaceuticals expects its nasal spray Ryaltris to hit about USD 80 million in sales next year, boosting its overall revenue, according to a top company executive. The drug firm has so far commercialised the product in 31 geographies across the globe. Ryaltris is indicated for symptomatic treatment of seasonal and perennial allergic rhinitis in adults and children over 12 years of age. The drug relieves symptoms of allergic rhinitis, including stuffy nose, runny nose, nasal itching, sneezing, as well as itchy, red and watery eyes. "Ryaltris is a huge product for us, right? I mean next year, we anticipate sales of close to about USD 80-odd million. So it's a very large product already in a short time," Glenmark Pharmaceuticals Chairman and Managing Director Glenn Saldanha said. The company is yet to launch the product in many of the major markets like China and Brazil, he added. Further, Saldana said, "So I think from peak sales, this will be a substantial product for us

Stocks to Watch today: RIL, Paytm, Vedanta, Coal India, Glenmark, NMDC

Stocks to watch on Thursday, February 15, 2024: In news today - Reliance eyes stake in Tata Play, Vedanta parent mulls stake sale to GQG Partners and ED launches probe in Paytm.

Utkarsh Small Finance Bank proposes reverse merger with holding entity

The bank has said it has taken note of the proposal and the Board of Directors of the lender will meet in due course and evaluate the proposal and other options to achieve regulatory compliance

Glenmark Pharma Q3 results: Standalone loss at Rs 20 cr, revenue dips 38.4%

Glenmark is going through a transitionary phase on account of divestment of Glenmark Life Sciences, says MD

Glenmark, Pfizer launch Abrocitinib in India for Atopic Dermatitis

The prevalence of atopic dermatitis in India has risen over the past three decades, with approximately 5.9 per cent of adults affected, of which 4.4 per cent suffer from a severe form of the disease

Battle shifts to new class of drugs in diabetes treatment in India

Glenmark Pharmaceuticals launched a biosimilar version of liraglutide earlier this month, after getting the nod from the Drugs Controller General of India (DCGI)

Glenmark expands global reach with cancer drug Envafolimab agreement

Envafolimab is a first-in-class PD-L1 inhibitor, a type of immunotherapy drug that harnesses the body's immune system to fight cancer

Glenmark cuts diabetes drug cost by 70% with first Indian biosimilar launch

Drug, marketed under the brand name Lirafit, is priced at approximately Rs 100 for a standard daily dose of 1.2 mg

Glenmark Pharmaceuticals launches antidiabetic drug 'Lirafit' in India

Glenmark Pharmaceuticals on Wednesday said it has launched a biosimilar of the popular antidiabetic drug, Liraglutide in India. The drug is being marketed under the brand name Lirafit following the approval from the Drug Controller General of India (DCGI), the company said in a statement. It is priced at around Rs 100 for a standard dose of 1.2mg (per day) and will lower the cost of therapy by approximately 70 per cent, the company claimed. Lirafit will be available only under prescription. "Clinical trials have shown that it helps improve glycemic control in adult type 2 diabetes mellitus patients along with atherosclerotic cardiovascular diseases (ASCVD) and obesity," Glenmark Pharmaceuticals President and Business Head India Formulations, Alok Malik said. Liraglutide has also proven to have a positive impact on cardiac and renal safety outcomes among patients in clinical trials, making it an effective choice of treatment for patients with type 2 diabetes mellitus, he added. "W

Dr Reddy's, Glenmark recall products in US due to manufacturing issues

Dr Reddy's Laboratories, Glenmark Pharma and Zydus are recalling products in the US market for manufacturing issues, according to the US Food and Drug Administration (USFDA). In its latest enforcement report, the US health regulator said Princeton-based Dr Reddy's Laboratories, Inc, a unit of the Hyderabad-based drug firm, is recalling 1,656 bottles of Montelukast sodium tablets. The product is indicated to prevent wheezing, breathing difficulty, chest tightness, and coughing caused by asthma in adults. As per the USFDA, the company is recalling the affected lot due to "the presence of foreign tablets and capsules." A foreign tablet was found in a bottle of Montelukast sodium tablets, USP 10mg, identified as metoprolol 25 mg, it added. The company initiated the Class II voluntary recall on October 13 this year. The USFDA noted that Mahwah-based Glenmark Pharmaceuticals Inc, USA, a unit of Mumbai-based Glenmark Pharma, is recalling 5,856 bottles of Deferasirox tablets for oral ...

India's Glenmark Pharma posts Q2 loss on exceptional legal costs

Glenmark incurred an exceptional cost of Rs 325 crore, during the quarter, related to a legal case settlement with US DoJ, Antitrust Division and remediation costs at manufacturing sites

Glenmark Pharmaceuticals receives USFDA approval for generic Prolixin

Prolixin is a prescription medication used to treat schizophrenia and other mental/mood disorders

Glenmark Pharma launches triple-combination drug for Type 2 Diabetes

Medication will be sold under the brand name Zita DM, will be priced at Rs 14 per tablet

Stocks to Watch today: Bajaj Finance, LTTS, Zensar, HUDCO, Glenmark, Biocon

Stocks to watch on Wednesday, October 18, 2023: Bajaj Auto, Bandhan Bank, IndusInd Bank, LTIMindtree and Wipro to be in focus ahead of Q2 results today.