Page 7 - Glenmark Pharmaceuticals

Glenmark Pharma, Teva settle drug pricing cases with US Dept of Justice

Teva will make a $50 million drug donation to humanitarian organizations that help Americans in need

Glenmark Pharma settles drug pricing case with US Department of Justice

Drug firm Glenmark Pharmaceuticals said it has entered into a pact with the US Department of Justice, Antitrust Division (DOJ) to resolve court proceedings related to the pricing of a drug. US-based Glenmark Pharmaceuticals Inc, a subsidiary of the company, has entered into a three-year deferred prosecution agreement with DOJ involving historical pricing practices by former employees relating to the generic drug pravastatin between 2013 and 2015, the Mumbai-based drug maker said in a regulatory filing. If the company adheres to the terms of the agreement, including the payment of USD 30 million, payable in six installments, the DOJ will dismiss the pending Superseding Indictment, it added. "Glenmark is committed to being a socially and ethically responsible company. We have devoted considerable resources to strengthen our compliance practices, ensuring the highest ethical operating standards. We will continue to conduct our business with the utmost transparency and integrity," ...

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Glenmark Pharma Q1 results: Profit after tax dips 22% to Rs 149.9 cr

Sequentially, the company exhibited a 0.8 per cent increase in revenue and managed to turn around the PAT, having reported a loss of Rs 428.3 crore in the previous quarter

Glenmark Pharma Q1 profit drops 22% to Rs 150 crore on higher expenses

Expenses also increased due to a one-time cost of Rs 5202 crore spent during the quarter for repairs at its various manufacturing facilities in India and the United States

Glenmark Pharmaceuticals gets USFDA nod to market generic diabetes drug

Glenmark Pharmaceuticals on Tuesday said it has received approval from the US health regulator to market a generic diabetes drug in the American market. The company has received final approval from the US Food & Drug Administration (US FDA) for Saxagliptin Tablets (2.5 mg and 5 mg), the generic version of AstraZeneca's Onglyza1 tablets, the Mumbai-based drug maker said in a statement. According to IQVIATM sales data, for the 12-month period ending June 2023, the Onglyza tablets (2.5 mg and 5 mg) achieved annual sales of around USD 100.7 million. Glenmark said its current portfolio now consists of 184 products authorized for distribution in the US market and 49 abbreviated new drug applications (ANDAs) are pending approval with the US FDA.

Nirma emerges as frontrunner for Glenmark's API arm as bid deadline ends

Nirma Ltd and Sekhmet Pharmaventures were among the shortlisted bidders for a controlling stake in GLS

Nirma, Sekhmet Pharmaventures vie for $731 mn Glenmark Life stake: Reports

Suitors have entered final round of bidding for stake of about 83% in Mumbai-listed company held by Glenmark Pharmaceuticals Ltd., said people, who asked not to be identified as information is private

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Glenmark Pharma slashes price of breast cancer drug Trastuzumab

Glenmark Pharmaceuticals Ltd on Thursday said it has slashed the price of breast cancer drug Trastuzumab by bringing its brand Trumab at Rs 15,749 for a 440 mg vial from Rs 54,000 earlier. Trastuzumab is used in the treatment of a particular type of breast cancer -- HER2-positive, and the company markets its version in India under the brand name 'Trumab'. "The new price of the drug being marketed under the brand name 'Trumab', will be Rs 15,749 per 440 mg vial. This price reduction will bring the per mg cost of Trumab to around Rs 35, making it the most affordable treatment option for HER2-positive breast cancer in the country," Glenmark said in a statement. Most of the existing Trastuzumab brands in the market are priced in between Rs 40,000 to Rs 54,000 per 440 mg vial, the company said, adding the cost of Trastuzumab treatment has been a major barrier for many patients in India. "Considering that a patient needs to undergo a minimum of 18 cycles (12 months) of treatment, the ...

Sekhmet Pharmaventures, Nirma in race to acquire Glenmark's API business

In the last three months, GLS's share price has risen by 52% from Rs 386 in anticipation of a transaction

Glenmark posts Q4 net loss at Rs 403 cr on one-time exceptional charge

Glenmark Pharmaceuticals on Friday reported a consolidated net loss of Rs 403 crore for the March 2023 quarter due to an exceptional charge of Rs 800 crore on account of the settlement of litigation related to a generic product in the US. The Mumbai-based drug maker had reported a net profit of Rs 172 crore for the January-March quarter of 2021-22. The company's consolidated revenue for the fourth quarter stood at Rs 3,374 crore compared to Rs 3,019 crore in the year-ago period, Glenmark Pharmaceuticals said in a regulatory filing. The net profit for FY23 stood at Rs 377 crore against Rs 994 crore in FY22. Its consolidated net revenues stood at Rs 12,990 crore in 2022-23 against Rs 12,305 crore in 2021-22. The profit for FY 2022-23 was lower primarily on account of the settlement of the litigation related to generic Zetia in the US, the drug maker said. "We delivered yet another year of robust performance, despite the challenging global macro-economic environment. Our India busin

Sensex ends 298 pts up, Nifty reclaims 18,200 led by Adani, auto, IT stocks

Stock Market Live on May 19, 2023: NTPC, Power Grid, Punjab National Bank, JSW Steel, Zomato, Glenmark Pharma and Delhivery will be on the radar ahead of their Q4 nos

Pharma companies seek price ceiling exemption for low-cost medicines

The industry and the government are on the same page on trade margin rationalisation, however, the industry wants it to be implemented in a phased manner

Glenmark Life Sciences profit surges 48% on API boost in March quarter

Revenue from Glenmark Life Sciences's API business, which accounts for about 90% of total revenue, grew 15.5% from last year

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Glenmark to pay $87.5 million to settle lawsuits over a product in US

Three plaintiff groups collectively representing all of the claims against the company and Merck are referred to as the Direct Purchaser Plaintiffs, the Retailer Plaintiffs, and the End-Payor Plaintif

Glenmark to pay $87.5 mn to settle lawsuits over a generic drug in US

Glenmark Pharmaceuticals on Tuesday it will pay USD 87.5 million to three plaintiff groups to settle multiple antitrust and consumer protection lawsuits in the US related to a generic drug. There were multiple antitrust and consumer protection lawsuits, including a class action, consolidated in the Eastern District of Virginia against the company and its subsidiary Glenmark Pharmaceuticals Inc. in connection with generic Zetia, a drug for the treatment of cholesterol, the Mumbai-based drug maker said in a regulatory filing. The lawsuits alleged that in 2010, Glenmark entered an anticompetitive agreement to settle patent infringement litigation involving a patent related to ezetimibe (the active ingredient in Zetia) with Schering Corporation and MSP Singapore Company LLC. The trial for the case began on April 19, 2023 in the US courts. Three plaintiff groups collectively representing all of the claims against the company and Merck are referred to as the Direct Purchaser Plaintiffs,

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 ..