Glenmark Pharmaceuticals

Glenmark gets USFDA nod for generic drug with 180-day exclusivity

Glenmark Pharmaceuticals on Thursday said it has received an approval from the US health regulator to market a generic medication to treat plaque psoriasis. The company has received final approval from the US Food & Drug Administration (USFDA) for Calcipotriene and Betamethasone Dipropionate Foam, the generic version of Leo Pharma's Enstilar, Glenmark Pharma said in a statement. The USFDA noted that the Mumbai-based drug firm was the first abbreviated new drug application (ANDA) applicant with a paragraph IV certification for Calcipotriene and Betamethasone Dipropionate Foam, it added. "Therefore, with this approval, Glenmark is eligible for 180 days of generic drug exclusivity for Calcipotriene and Betamethasone Dipropionate Foam," the drug firm said. According to IQVIA sales data for the 12-month period ended January 2023, Enstilar Foam (0.005 per cent/0.064 per cent) achieved annual sales of around USD 93.6 million. Shares of the company were trading 0.49 per cent down at Rs ..

Glenmark gets USFDA nod to market generic medication to treat schizophrenia

Glenmark Pharmaceuticals on Monday said it has received approval from the US health regulator to market a generic product used to treat schizophrenia and in some cases to control severe nausea. The company has received nod from the US Food & Drug Administration (USFDA) for Prochlorperazine Maleate Tablets USP, 5 mg and 10 mg, the Mumbai-based drug maker said in a statement. The company's product is the generic version of GlaxoSmithKline's Compazine tablets, it added. According to IQVIA sales data for the 12-month period ending January 2023, the Compazine tablets 5 mg and 10 mg achieved annual sales of around USD 26.9 million. Glenmark said its current portfolio consists of 182 products authorised for distribution in the US marketplace and 46 ANDAs (Abbreviated New Drug Applications) pending approval with the USFDA. PTI MSS.

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The derivative analyst from HDFC Securities recommends to Buy Glenmark Pharma 440 CALL at Rs 7 & simultaneously sell 450 CALL at Rs 4 of March series

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Glenmark Pharma get USFDA nod for human trial of cancer-treating drug

Glenmark Pharmaceuticals on Thursday said its arm has received acceptance from the US health regulator to proceed with a phase 1/2, first-in-human trial for its investigational new drug aimed for treatment of patients with advanced cancers. In a regulatory filing, the company said Glenmark Specialty SA received the acceptance from the US Food and Drug Administration (USFDA) for the investigational new drug (IND) application 'GRC 54276' for the treatment of patients with advanced solid tumours and lymphomas. Developed by Glenmark, GRC 54276 is an orally available, small molecule hematopoietic progenitor kinase 1 (HPK1) inhibitor. HPK1-regulated functions are involved in nearly every step of the cancer-immunity cycle, making it an attractive target for immuno-oncology, the company said. By inhibiting HPK1, GRC 54276 is designed to potentially enhance the patient's own immune system to fight cancers, it added. "Now that the (US)FDA has accepted our IND application, we look forward to

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Glenmark Pharma receives USFDA approval for generic antibiotic drug

Glenmark Pharmaceuticals on Tuesday said it has received approval from the US health regulator to market a generic antibiotic drug. The company has received final approval from the US Food & Drug Administration (USFDA) for Clindamycin Hydrochloride Capsules, a generic version of Pfizer's Cleocin capsules, Glenmark Pharma said in a statement. Glenmark's Clindamycin Hydrochloride Capsules in strengths of 75 mg, 150 mg, and 300 mg, will be distributed in the US by Glenmark Pharmaceuticals Inc, it added. According to IQVIA sales data for the 12-month period ending January 2023, the Cleocin Hydrochloride Capsules, 75 mg, 150 mg, and 300 mg achieved annual sales of around USD 33.6 million. Glenmark shares were trading 0.12 per cent up at Rs 426.10 apiece on the BSE.

Nandish Shah recommends a Bull Spread on Glenmark Pharma for March expiry

The derivative analyst from HDFC Securities recommends to Buy Glenmark 460 Call and simultaneously Sell 480 Call of the March series.

Glenmark Pharma jumps 5% post December quarter earnings

The company reported a 21 per cent surge in Q3 consolidated net at Rs 291 crore.

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Glenmark Pharma December quarter PAT rises by 21.3% to Rs 290.8 crore

Glenmark Pharmaceuticals Ltd on Friday reported a 21.3 per cent rise in consolidated profit after tax at Rs 290.8 crore for the third quarter ended December 31, 2022. The company had posted a consolidated consolidated profit after tax of Rs 239.8 crore in the corresponding quarter last fiscal, Glenmark Pharma said in a statement. Consolidated revenue was at Rs 3,463.9 crore, as against Rs 3,173.4 crore, up 9.2 per cent, it added. "We had yet another quarter with a strong performance led by robust growth across all our markets despite the challenging macroeconomic conditions," Glenmark Pharmaceuticals Chairman & Managing Director Glenn Saldanha said. The company's India business continued to record a healthy increase in secondary sales, while the US business recovered well as the year progressed and the rest of world and EU businesses also reflected formidable growth during the quarter, he added. Sales from the India formulation business in the third quarter were at Rs 1,074.5 ...

Glenmark Life Sciences profit rises 1% in Dec quarter on API strength

The Mumbai-based drug maker's profit rose to 1.05 billion rupees ($12.86 million) in the three months ended Dec. 31, from 1.04 billion rupees a year ago

Glenmark pharma launches generic version of Novartis' heart failure drug

Opens floodgates for more generic launches; 40 new brands expected

Glenmark Pharmaceuticals launches drug to treat heart failure in India

Its approved indication is to reduce the risk of cardiovascular related deaths and hospitalisations for patients with chronic heart failure with HFrEF

Glenmark launches generic version of diuretic Bumetanide injection

Glenmark Pharmaceuticals Ltd on Tuesday said its US arm has launched its generic version of diuretic Bumetanide injection. In a statement the company said Glenmark Pharmaceuticals Inc., USA (Glenmark) launched Bumetanide Injection of strengths of 1 mg/4 mL (0.25 mg/mL) single-dose vials and 2.5 mg/10 mL (0.25 mg/mL) multi-dose vials. These are the generic version of Bumex injection, 0.25 mg/mL, of Validus Pharmaceuticals LLC, it added. The launch affirms commitment to Glenmark's continued focus on institutional business, company Senior Vice President, Business Development Portfolio, Product Launch & Strategy, Vijay Raghavan said. The Bumex injection, 0.25 mg/mL achieved annual sales of approximately USD 16.5 million, the company said citing IQVIA sales data for the 12-month period ended November 2022.

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The derivative analyst from HDFC Securities expects Glenmark Pharma January futues to test Rs 450 on the upside.

Shankar Sharma at BFSI Summit: Budget 2023 shouldn't tinker with LTCG tax

Market closing: The S&P BSE Sensex dropped 241 points to end at 60,826 levels in a broad-based sell-off. The Nifty50 gave up the 18,150-mark to close at 18,127, down 72 points

Glenmark Pharma launches combination drug for Type 2 diabetic patients

Glenmark Pharmaceuticals Ltd on Wednesday said it has launched triple fixed-dose combination Teneligliptin with Pioglitazone and Metformin in India for diabetic patients. This fixed-dose combination offers patients with Type 2 diabetes the convenience of once daily dosing to improve their glycemic control. It is priced at Rs 14.90 per day, thereby reducing the daily cost of therapy by 40 per cent, making it more affordable to the masses, the company said in a statement. It has been launched under the brand name Zita-PioMet, and contains Teneligliptin (20 mg), Pioglitazone (15 mg) and Metformin (500mg/1000mg) in a sustained release (SR) formulation, it added. "Type 2 diabetes patients in India often face issues of beta cell dysfunction along with insulin resistance. In fact, the prevalence of high insulin resistance in India is 38 per cent compared to the global incidence of 15 per cent," Glenmark Pharmaceuticals EVP & Business Head - India Formulations Alok Malik said. The market .

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USFDA issues warning letter to Glenmark Pharma for lapses at Goa plant

The US health regulator has pulled up drug maker Glenmark Pharmaceuticals for manufacturing lapses, including failure to establish required laboratory control mechanisms, at its Goa-based manufacturing plant. In a warning letter addressed to Glenmark Pharmaceuticals Chairman and Managing Director Glenn Saldanha, the US Food and Drug Administration (USFDA) pointed out various lapses at the company's Bardez-based facility in Goa, which produces drug formulations. The US Health regulator noted that the "warning letter summarises significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals". It further said: "Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated..." The USFDA inspected the manufacturing facility from May 12, 2022, to May 20, 2022. In the warning letter, the US health regulator pointed out the company's failure "to ...