Merck's anti-diabetic molecule sitagliptin retains 81% market share in value terms
Glenmark Pharmaceuticals on Tuesday said it has entered into a settlement agreement with Pfizer Inc regarding a cancer treatment drug. The Mumbai-based drug maker and its US-based unit have inked a settlement pact with drug major Pfizer Inc for Axitinib Tablets (1 mg and 5 mg). Glenmark's product is the generic version of Pfizer's Inlyta tablets, used to treat kidney cancer. According to IQVIATM sales data for the 12-month period ending September 2022, the Inlyta tablets (1 mg and 5 mg) achieved annual sales of around USD 644.5 million. Glenmark said its current portfolio consists of 177 products authorised for distribution in the US marketplace and 47 abbreviated new drug applications (ANDA's) are pending for approval with the US Food and Drug Administration. Shares of of the drug maker were trading 1.54 per cent up at Rs 417.9 apiece on BSE.
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Glenmark Pharmaceuticals on Friday said its profit after tax (PAT) rose marginally to Rs 279 crore for the second quarter ended September 30, 2022. The Mumbai-based drug firm had reported a PAT of Rs 275 crore in the July-September period of the previous fiscal. Consolidated revenue rose to Rs 3,375 crore in the period under review as against Rs 3,147 crore in the year-ago quarter, Glenmark Pharma said in a regulatory filing. "We delivered yet another quarter of consistent growth, with our relentless focus on launching differentiated products in our core therapeutic areas," Glenmark Pharmaceuticals Chairman and Managing Director Glenn Saldanha said. The company's domestic business recorded strong double-digit growth and Europe business also performed very well in spite of a challenging macro-economic environment, he added. "We look forward to launching new products across markets and building global scale in our respiratory portfolio," Saldanha said.
According to the technical analyst from Anand Rathi, Glenmark Pharma can surge to Rs 460, while Muthoot Finance can rally to Rs 1,175.
Glenmark Pharmaceuticals on Wednesday said it has received approval from the US health regulator to market Sodium Phenylbutyrate tablets, used in treating urea cycle disorders, in America. The company has received final approval from the US Food and Drug Administration (USFDA) for the product which is a generic version of Horizon Therapeutics' Buphenyl, the Mumbai-based drug maker said in a statement. According to IQVIA sales data for 12-month period ended September 2022, Buphenyl had annual sales of around USD 8.7 million. Glenmark's current portfolio consists of 177 products authorised for distribution in the US marketplace and 46 abbreviated new drug applications (ANDAs) pending approval with the USFDA.
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Glenmark Pharmaceuticals on Wednesday said the US health regulator has put its manufacturing plant at Baddi under import alert. The drugs produced at the Baddi unit can now be detained without physical examination. The US Food and Drug Administration inspected the facility in June 2022 and subsequently placed it under "Official Action Indicated" status. The OAI classification implied that the USFDA may withhold approval of any pending product applications or supplements filed from such facility till the outstanding observations related to non-compliance with manufacturing norms laid down by the regulator. "We now wish to inform you that the US FDA has placed the Baddi (India) facility under import alert 66-40," Glenmark Pharmaceuticals said in a regulatory filing. As per the USFDA, import alert 66-40 implies detention without physical examination of drugs from firms which have not met drug GMPs. "The US revenues from products supplied from this facility contributed to 1-2 per cen
Glenmark Pharmaceuticals on Thursday said it has launched a fixed-dose combination for the treatment of diabetes for patients with comorbidities. The Mumbai-based drug maker said it has become the first company to launch Teneligliptin (20mg) + Dapagliflozin (5mg/10mg) fixed-dose combination for the treatment of adult patients with type 2 diabetes. Marketed under the brand name Zita D, it contains Teneligliptin (20mg) + Dapagliflozin (5 mg/10 mg), and must be taken once daily under prescription to improve glycemic control and prevent complications in adult patients with type 2 diabetes, especially the ones with comorbidities, Glenmark Pharma said in a statement. "Diabetes is growing in India at an alarming rate, and eight out of every ten diabetic patients suffer from comorbidities," Glenmark Pharmaceuticals EVP & Business Head India Formulations Alok Malik said. The new drug is well researched and affordable fixed-dose combination, which will significantly improve glycemic control
Glenmark Pharmaceuticals on Thursday said it has launched Thiazolidinedione Lobeglitazone in the country for the treatment of type 2 diabetes in adults. The Mumbai-based drug firm has launched the medication under the brand name LOBG and is priced at around Rs 10 per tablet. Indians have a high prevalence of insulin resistance and that makes LOBG an appealing treatment option in managing uncontrolled Type 2 diabetes among insulin-resistant diabetic patients, Glenmark Pharmaceuticals said in a statement. The company had received approval from the Indian drug regulator, Drug Controller General of India, for manufacturing and marketing Lobeglitazone, based on a randomised, double-blind Phase 3 clinical trial conducted on adult Type 2 diabetic patients, aged 18 years and older. "As per the International Diabetes Federation, diabetes affects 74 million adults in India, of which, around 40 per cent of them seem to be insulin-resistant... "We are proud to introduce LOBG; an innovative an
Company promoters bought shares even when they held more than 75 per cent
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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