Page 15 - Glenmark Pharmaceuticals

Glenmark Pharma gets USFDA approval for prostate cancer treatment drug

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 Pharma gets tentative nod from USFDA for multiple sclerosis drug

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.

Glenmark stock tumbles to 52-week low on USFDA warning letter to Baddi unit

Plant accounts for 7 per cent of company's US sales; firm says no major pending approvals from unit in the next 12 months

USFDA warning letter for Glenmark's Baddi unit, reason classified

The United States Food and Drug Administration (USFDA) had inspected the facility between April 15 and April 20 and earlier classified the inspection as an official action indicated

Glenmark Pharma shareholders approve raising $200 mn via debt securities

The proposal was approved at the company's annual general meeting held on September 27

Glenmark plans to divest non-core global assets to reduce debt by Rs 800 cr

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 receives final nod from USFDA for drug to treat chronic angina

Glenmark Pharmaceuticals Tuesday said it has received final nod from the US health regulator for its Ranolazine extended-release tablets used for treatment of chronic angina. Glenmark Pharmaceuticals Inc has been granted final approval by the United States Food & Drug Administration (USFDA) for Ranolazine extended-release tablets in the strengths of 500 mg and 1,000 mg, the company said in a statement. The product is a generic version of Gilead Sciences Inc's Ranexa extended-release tablets in the same strengths, it added. According to IQVIA sales data for the 12-month period ended May 2019, Ranexa extended-release tablets, 500 mg and 1,000 mg market (which includes brand and all available therapeutic equivalents) achieved annual sales of around USD 929 million, Glenmark said. The company's current portfolio consists of 158 products authorised for distribution in the US marketplace and 57 abbreviated new drug applications (ANDAs) pending approval with the USFDA, it ...

Glenmark Pharmaceuticals stock slips to 6-year low on USFDA woes

The company further said it would continue to pursue regulatory approval for Ryaltris

Glenmark signs deal with Novartis for 3 respiratory products in Brazil

Under the terms of the agreement, Novartis will remain the holder of the registration of these medicines and will be responsible to manufacture them

Glenmark Pharma receives final approval from USFDA for antiplatelet drug

Glenmark Pharmaceuticals Monday said it has received final approval from the US health regulator for antiplatelet agents Aspirin and extended-release Dipyridamole capsules. The approved product is a generic version of Aggrenox capsules of Boehringer Ingelheim Pharmaceuticals Inc. Glenmark Pharmaceuticals Inc, USA has been granted final approval by the United States Food & Drug Administration (USFDA) for Aspirin and extended-release Dipyridamole capsules in the strength of 25 mg/200 mg, the company said in a BSE filing. Citing IQVIA sales data, Glenmark said, the Aggrenox capsules, 25 mg/200 mg market achieved annual sales of approximately USD 165.6 million in the 12-month period ended March 2019. The company said its current portfolio consists of 155 products authorised for distribution in the US and 58 Abbreviated New Drug Application (ANDA's) pending approval with the USFDA. Shares of Glenmark Pharma were trading 0.03 per cent higher at Rs 559.20 apiece on the BSE.

Glenmark Pharma: Acid reflux capsules get US FDA nod, shares rise

Glenmark Pharmaceuticals Tuesday said it has received final approval from the US health regulator for generic version of AstraZeneca's Nexium, used to treat acid reflux. Glenmark Pharmaceuticals Inc, USA has been granted final approval by the United States Food & Drug Administration (US FDA) for Esomeprazole Magnesium delayed-release capsules USP in the strengths of 20 mg and 40 mg, the company said in a BSE filing. The approved products is a generic version of AstraZeneca Pharmaceuticals' Nexium delayed-release capsules. Citing IQVIA sales data, Glenmark said, Nexium delayed-release capsules, 20 mg and 40 mg achieved annual sales of around USD 395.1 million in the 12-month period ended March 2019. The company said its current portfolio consists of 153 products authorised for distribution in the US and 58 ANDA's pending approval with the USFDA. Shares of Glenmark Pharma were trading 0.46 per cent higher at Rs 594.35 apiece on BSE.

R&D spin-off may help Glenmark Pharma to cut investment risks, reduce debt

But US growth hinges on product approvals and pace of price erosion

Glenmark Pharma gets USFDA nod for generic skin inflammation treatment foam

The company said its current portfolio consists of 150 products authorised for distribution in the US and 52 ANDA's pending approval with the USFDA

Glenmark Pharmaceuticals forays into branded dermatology segment in US

Glenmark is already present in generic dermatology market in the US

Glenmark Pharma up 5% on USFDA nod for Hydrocortisone Valerate

The stock was up 5% to Rs 698, trading close to its 52-week high of Rs 712 touched on September 10, 2018 on BSE in the intra-day trade.

Glenmark receives USFDA nod for Azelaic Acid gel for treating acne

Glenmark has a portfolio comprising 143 products authorised for distribution in the US market and 56 ANDAs pending approval with the USFDA

Glenmark Pharmaceuticals Q2 net profit jumps 93.3% at Rs 4.14 billion

Glenmark Pharmaceuticals Tuesday reported a 93.3 per cent jump in consolidated net profit at Rs 414 crore for the quarter ending September boosted by sale of its orthopaedic and pain management business in India. The company had posted consolidated net profit of Rs 214.12 crore in the previous corresponding quarter, Glenmark Pharmaceuticals said in a statement. During the period under review, consolidated revenue was at Rs 2,581.33 crore against Rs 2,256.59 crore in the year-ago period. In the second quarter, the company had one-time exceptional income of Rs 167.18 crore. Glenmark had transferred its orthopaedic and pain management India business, valued at Rs 6.35 crore to Integrace Pvt Ltd by way of a slump sale during the second quarter. Commenting on the performance, Glenmark Pharmaceuticals Chairman & MD Glenn Saldanha said,"Our healthy performance in the second quarter can be attributed to good growth in most of our markets globally." The US business growth was driven by .

Glenmark pharma gets USFDA nod for generic Derma-Smoothe Topical Oil

Glenmark Pharmaceuticals Tuesday said it has received final approval from the US health regulator for generic version of Derma-Smoothe Topical Oil, used in the treatment of scalp psoriasis. "Glenmark Pharmaceuticals Inc, USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (USFDA) for Fluocinolone Acetonide Topical Oil, 0.01 per cent (scalp oil), a generic version of Derma-Smoothe/FS Topical Oil, 0.01 per cent (scalp oil), of Hill Dermaceuticals, Inc," the company said in a BSE filing. For the 12 months to September 2018, DermaSmoothe/FS Topical Oil, 0.01 per cent (scalp oil), achieved annual sales of around USD 14 million, Glenmark said, citing IQVIA sales data. The company's current portfolio consists of 141 products authorised for distribution at the US marketplace and 58 Abbreviated New Drug Applications (ANDAs) pending approval with the USFDA. The company's stock was trading at Rs 607.35 apiece, up 0.41 per cent, on the BSE.

Glenmark's generic oil for skin inflammation treatment gets USFDA nod

Glenmark Pharmaceuticals Friday said its US arm has received final nod from the US health regulator for generic Fluocinolone Acetonide Topical oil used for treatment of inflammation of skin. Glenmark Pharmaceuticals Inc has been granted final approval by the United States Food & Drug Administration (USFDA) for the oil in the strength of 0.01 per cent, the Mumbai-based company said in a statement. The product is a generic version of Hill Dermaceuticals Inc's Derma-Smoothe/FS Topical oil in the same strength, it added. The body oil is indicated for the topical treatment of atopic dermatitis in adult patients. "According to IQVIA sales data for the 12 months ended August 2018, the Derma-Smoothe/FS Topical oil, 0.01 per cent market (including brand and available therapeutic equivalents) achieved annual sales of approximately USD 14.5 million," Glenmark Pharma said. The company's current portfolio consists of 140 products authorised for distribution in the US and 60 abbreviated new ...

Glenmark gets USFDA nod for generic Westcort cream used for skin conditions

Drug firm Glenmark Pharmaceuticals Monday said it has received final nod from the US health regulator for generic Hydrocortisone Valerate cream used for providing relief in inflammation and itching due to various skin conditions. Glenmark Pharmaceuticals Inc has been granted final approval by the United States Food & Drug Administration (USFDA) for Hydrocortisone Valerate Cream USP, 0.2 per cent, Glenmark said in a statement. The product is a generic version of Sun Pharmaceutical Industries Inc's Westcort Cream in the same strength, it added. According to IQVIA sales data for the 12-month period ending August 2018, the Westcort Cream, 0.2 per cent market achieved annual sales of around USD 17 million, Glenmark said. The company's current portfolio consists of 139 products authorised for distribution in the US marketplace and 60 abbreviated new drug applications (ANDA's) pending approval with the USFDA, Glenmark said. Shares of Glenmark Pharmaceuticals were today trading at Rs ...