Page 9 - Glenmark Pharmaceuticals

Stocks to watch: Zee Ent, SBI Cards, Tata Chemicals, Glenmark Pharma, Dabur

Stocks to watch today: SBI Cards, Indus Towers will report July-September quarter results on Thursday, October 27; Sony India and Zee Ent plan to sell 3 Hindi channels to address anti-competition

USFDA issues import alert on Glenmark Pharma's Baddi manufacturing plant

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 Pharma launches drug for diabetic patients with comorbidities

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 launches drug to treat patients with insulin-resistant diabetes

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

Shareholding gaffe at Glenmark Life: Focus shifts to Sebi new rules

Company promoters bought shares even when they held more than 75 per cent

NLEM 2022: Analysts see no major impact pharma companies' growth

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

Glenmark Pharma launches Ryaltris nasal spray for allergic rhintis in US

British drugmaker Hikma to distribute Ryaltris while Glenmark will manufacture it

US biz growth in FY23 expected to be flat or low single-digit: Glenmark

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 ...

Drug makers Glenmark, Sun Pharma, Dr Reddy's recall products in US

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

Glenmark Pharmaceuticals' Q1 net profit drops 31% to Rs 211.1 crore

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 Pharma arm gets final USFDA nod for birth control capsules

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.

Stocks to watch: Infosys, RIL, ICICI Bank, YES Bank, Glenmark, Tata Motors

Stocks to watch today: Axis Bank, Tata Steel will report their June quarter 2022 results (Q1FY23) on Monday, July 25; Infosys delivered net profit for Q1 below street expectations at Rs 5,360 crore.

Sun Pharma, Glenmark recall products in US due to manufacturing issues

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 ...

Sensex snaps 4-day losing run, up 345 pts; Nifty tops 16K; Auto, FMCG lead

CLOSING BELL: Tata Consumer Products, Titan, Eicher Motors, HUL, Tata Motors, Maruti, M&M, Nestle India, HDFC, L&T, and BPCL topped the charts

Stocks to watch: ACC, L&T Tech, L&T Infotech, JSPL, Glenmark, Tata Elxsi

Stocks to watch today: L&T Technology Services and Jindal Steel and Power will share June quarter 2022 (Q1FY23) results on Friday, July 15.

Glenmark nasal spray cuts down viral load of Covid by 94% in 24 hrs

Glenmark had conducted the study on 306 vaccinated and unvaccinated adults with symptomatic mild Covid-19 disease across 20 clinical trial sites in India

Stocks to watch: Reliance, Tata Motors, Biocon, Tata Steel, J&K Bank, BoB

Stocks to watch today: Akash M Ambani will take over as non-executive director and chairman of the board of directors of Reliance Jio; Tata Motors will hike prices of CVs by 1.5 to 2.5 per cent.

Glenmark acquires Wockhardt's key OTC brands in US for undisclosed sum

Deal includes approved ANDAs for famotidine tablets, used in treatment and prevention of ulcers stomach and intestinal ulcers

Glenmark Pharmaceuticals acquires certain OTC drugs from Wockhardt in US

Glenmark said its current portfolio consists of 175 products authorised for distribution in the US market and 48 ANDAs pending approval with the USFDA

Sensex rallies 443 pts; Nifty holds 15,550; Maruti rises 7%, Hero Moto 6%

CLOSING BELL: Maruti Suzuki, Eicher Motors, Hero MotoCorp, Bajaj Auto, M&M, and Tata Motors were the top Nifty gainers, advancing between 3.5 per cent and 6.7 per cent