The 2022 revision of the NLEM came after seven years. Most drugs that have been now brought into the NLEM include anti-infectives, anti-diabetics, anesthetics, etc
British drugmaker Hikma to distribute Ryaltris while Glenmark will manufacture it
Glenmark Pharmaceuticals expects growth of its US business to be flat or at low single digit in 2022-23 amid challenges of price erosion and unpredictable product approval by the USFDA, according to a senior company official. The company's North America business, including the US, recorded a revenue of Rs 662.8 crore in April-June 2022 as compared to Rs 787.8 crore in the year-ago period, down 15.9 per cent. It accounted for 23.9 per cent of consolidated sales in the quarter. In the first quarter, Glenmark's consolidated revenues from operations stood at Rs 2,777.3 crore as against Rs 2,964.9 crore in the corresponding period last year, a decline of 6.3 per cent. "We are looking at flat to low single-digit growth in the US for FY23 compared to FY22," Glenmark Pharmaceuticals Ltd CEO - Global Formulations business Brendan O' Grady told analysts. He was responding to a query on the outlook for the US business and reasons for decline in sales in the country. "The US business is ...
Leading generic drug makers Glenmark, Sun Pharma, Dr Reddy's and Jubilant Cadista are recalling multiple products in the US market, the world's largest market for medicines, for various issues
Adjusted Ebidta was Rs 4,72.6 crore in the quarter ended June 30, 2022 as against Rs 5,73.6 crore in the previous corresponding quarter, with margins of 17 per cent
Glenmark Pharmaceuticals Ltd on Friday said its US arm has received final approval from the US health regulator for its generic Norethindrone Acetate and Ethinyl Estradiol Capsules and Ferrous Fumarate birth control capsules. The approval granted by the US Food & Drug Administration (USFDA) to Glenmark Pharmaceuticals Inc is for Norethindrone Acetate and Ethinyl Estradiol Capsules and Ferrous Fumarate Capsules of strength 1 mg/20 mcg, the company said in a statement. It is the generic version of Taytulla capsules of Allergan Pharmaceuticals International Ltd, it added. Citing IQVIA sales data for the 12 months ended May 2022, the company said the Taytulla Capsules market achieved annual sales of approximately USD 85.9 million.
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Leading drug makers Sun Pharma and Glenmark are recalling products in the US, the world's largest market for medicines, due to lapses in the manufacturing process. As per the latest enforcement report by the US Food and Drug Administration (USFDA), a US-based unit of Sun Pharma is recalling 50,680 vials of Testosterone Cypionate Injection, used to treat low testosterone in adult males, in the American market. According to the US health regulator, the Mumbai-based drug major is recalling the affected lot due to "water leakage" leading to deviation from current good manufacturing practices (cGMP). The company is also recalling 27 vials of the same medication due to cGMP deviations, USFDA said. "Manufacturing deviations were reported due to an abnormal appearance on parts of machinery," it added. The affected lot was produced at Sun Pharma's Halol (Gujarat) based manufacturing plant. New Jersey-based Sun Pharmaceutical Industries Inc, a unit of the company, initiated the Class II ...
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Glenmark had conducted the study on 306 vaccinated and unvaccinated adults with symptomatic mild Covid-19 disease across 20 clinical trial sites in India
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Deal includes approved ANDAs for famotidine tablets, used in treatment and prevention of ulcers stomach and intestinal ulcers
Glenmark said its current portfolio consists of 175 products authorised for distribution in the US market and 48 ANDAs pending approval with the USFDA
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Stocks to Watch today: The US FDA has issued Glenmark Pharma form 483 with 6 observations for its Baddi Unit, which was inspected between June 13-22, 2022.
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Company says treatment will be affordable and improve lung function of patients
Glenmark Pharmaceuticals on Thursday said it has launched a novel fixed-dose combination (FDC) drug in the country for patients with uncontrolled asthma. The Mumbai-based drug major has launched - Indacaterol + Mometasone FDC under the brand name Indamet. The drug will be available in three strengths with a fixed dose of Indacaterol 150 mcg and variable doses of Mometasone 80 mcg, 160 mcg and 320 mcg to be taken once daily. "Respiratory is a key focus area for Glenmark, and the company leads from the front in providing access to the latest treatment options to patients. "We are proud to introduce this novel fixed-dose combination Indamet, which is the first of its kind in India, offering an affordable treatment option to both adults and adolescents 12 years of age and older suffering from uncontrolled asthma," Glenmark Pharmaceuticals Group Vice President & Head (India Formulations) Alok Malik said in a statement. The drug maker is the first company in India to market the FDC of .
Strong sales in Q4 during war aided by 'stocking up of inventory'