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'
Glenmark Pharmaceuticals on Saturday said its consolidated profit after tax declined 26 per cent to Rs 173 crore for the fourth quarter ended March 31, 2022.
Glenmark Pharmaceuticals on Monday said its US-based arm has received tentative approval from the US health regulator for its generic Calcipotriene and Betamethasone Dipropionate foam used to treat psoriasis. The tentative approval granted to Glenmark Pharmaceuticals Inc, USA (Glenmark) by the US Food & Drug Administration (USFDA) is for Calcipotriene and Betamethasone Dipropionate foam of strength 0.005 per cent/0.064 per cent, the company said in a statement. It is the generic equivalent of Leo Pharma AS' Enstilar foam, it added. Citing IQVIATM sales data for the 12 months ended March 2022, the company said Enstilar foam, 0.005 per cent/0.064 per cent achieved annual sales of approximately USD 115.2 million. Glenmark said its current portfolio consists of 174 products authorised for distribution in the US marketplace and 48 abbreviated new drug applications (ANDAs) are pending approval with the USFDA.
Glenmark Pharmaceuticals on Monday said it has launched a novel fixed-dose combination (FDC) of Teneligliptin, with Pioglitazone in India for adults with uncontrolled Type 2 diabetes. Glenmark has launched this FDC under the brand name Zita Plus Pio, which contains Teneligliptin (20 mg) and Pioglitazone (15 mg), to be taken once a day, the company said in a statement. Diabetes is a key area of focus for Glenmark; a pioneer in providing access to the latest treatment options to diabetic patients in India. We are delighted to introduce this novel Zita Plus Pio, which is the first of its kind in India; offering a world-class and affordable treatment option to adult diabetic patients, Glenmark Pharmaceuticals Group Vice President & Head, India Formulations Alok Malik said. Glenmark claimed it is the "first company in India to market the innovative FDC of Teneligliptin + Pioglitazone, which is approved by the DCGI (Drug Controller General of India)" "This fixed-dose combination will be