Glenmark had appealed to the pricing regulator in 2016 asking for a differential price for its Digihaler
CLSA has increased the target price of the firm to Rs 410 from Rs 350 earlier and raised its FY20-22 earnings per share (EPS) by 3 per cent - 22 per cent.
Glenmark's total expenses was at Rs 2,548.56 crore during the period as against Rs 2,308.80 crore, up 10.38%
The company's US-based arm is recalling the lots of the product used for providing relief from menopause symptom
Most of these companies have seen a sharp erosion in their market values in the wake of the yearlong crisis in India's credit market
Drug firm Glenmark Pharmaceuticals on Thursday said it has received final approval from the US health regulator for Abiraterone Acetate tablets, used to treat prostate cancer. The approved product is a generic version of Zytiga tablets, 250 mg, of Janssen Biotech. "Glenmark Pharmaceuticals Inc., USA has been granted final approval by the United States Food & Drug Administration (USFDA) for Abiraterone Acetate tablets USP, 250 mg," the company said in a regulatory filing. Quoting IQVIA sales data for the 12 month period ending August 2019, Glenmark said the Zytiga tablets, 250 mg market achieved annual sales of approximately USD 794.1 million. Glenmark's current portfolio consists of 162 products authorised for distribution in the US marketplace and 46 ANDA's pending approval with the USFDA. Shares of Glenmark Pharma were trading 0.15 per cent higher at Rs 286.00 apiece on the BSE.
Glenmark Pharmaceuticals on Wednesday said it has received tentative nod from the US health regulator for dimethyl fumarate delayed-release capsules used for treating multiple sclerosis. The tentative nod granted by US Food & Drug Administration (USFDA) to Glenmark Pharmaceuticals Inc, USA (Glenmark) is for multiple strengths of dimethyl fumarate delayed-release capsules of 120 mg and 240 mg. These are generic version of Tecfidera Capsules, 120 mg and 240 mg, of Biogen Inc, Glenmark Pharmaceuticals said in a statement. Citing IQVIATM sales data for the 12 month period ending August 2019, the company said Tecfidera Capsules, 120 mg and 240 mg achieved annual sales of approximately USD 3.7 billion. Glenmark's said its current portfolio consists of 161 products authorised for distribution in the US market and 49 abbreviated new drug applications (ANDAs) pending approval with the USFDA.
The Nifty Pharma index fell 3.35 per cent during the day.
The USFDA had inspected the company's Baddi facility between April 15 and April 20 and had earlier classified the inspection as an "Official Action Indicated".
The proposal was approved at the company's annual general meeting held on September 27
Monetisation of API, innovative business units planned this year
Glenmark's capex for the first quarter of fiscal 2020 was Rs 190 crore, in line with its guidance
Apart from rationalising costs, the company is also aiming to divest some of its non-core global assets as well as bring in a minority investor in to Glenmark Life Sciences
Glenmark Pharmaceuticals plunged 9 per cent, while Dr Reddy's slipped 8 per cent in intra-day trade
Glenmark launched Remogliflozin, indicated in the treatment of Type 2 Diabetes Mellitus in adults under the brand names Remo and Remozen
The CRL cites deficiencies in the Drug Master File pertaining to one of the active pharmaceutical ingredients and in manufacturing facilities, the company said in a regulatory filing
Riva's appointment as CEO of Glenmark's innovation business is effective from April 2.
Shares of Glenmark Pharmaceuticals were trading 1.02% higher at Rs 656.10 apiece on the BSE
The approved product is a generic version of Janssen Biotech Inc's Zytiga tablets
Glenmark Pharmaceuticals Monday said it has received tentative nod from the US health regulator for Clobetasol Propionate foam, used to treat inflammation and itching caused by a number of skin conditions like eczema. Glenmark Pharmaceuticals Inc USA has been granted tentative approval by the United States Food & Drug Administration (US FDA) for Clobetasol Propionate Foam, 0.05 per cent (Emulsion Formulation), the company said in a BSE filing. The approved product is a generic version of Mylan Pharmaceuticals Inc's Olux-E Foam, 0.05 per cent. Quoting IQVIA sales data for the 12-month period ended September 2018, Glenmark Pharmaceuticals said, Olux-E Foam achieved annual sales of around USD 13.2 million. The company's current portfolio consists of 144 products authorised for distribution in the US market and 55 abbreviated new drug applications (ANDAs) pending approval with the USFDA, it added. Shares of Glenmark Pharmaceuticals were trading 0.06 per cent lower at Rs 637.45 apiece