Page 8 - Glenmark Pharmaceuticals

HUL zooms 10% after announcing acquisition of Vwash from Glenmark

Glenmark will manufacture VWash for HUL over the next one year after which the production arrangement would be reviewed

Glenmark gets tentative nod from USFDA for generic type-2 diabetes tablets

The product is a generic version of AstraZeneca AB's Farxiga tablets

More drug licensing deals will play a big part in paring Glenmark's debt

The company's US sales growth has remained subdued due to intense competition for its dermatology range.

Glenmark Pharma shines as September quarter marks rebound in earnings

Analysts are upgrading their ratings as they expect sales momentum in the US and domestic markets to improve

Glenmark Pharma net declines 38% to Rs 255.54 cr in September quarter

Glenmark's total expenses was at Rs 2,548.56 crore during the period as against Rs 2,308.80 crore, up 10.38%

New FDA warning letters show Indian drug makers' quality concerns persist

The latest regulatory crackdown shows US regulator's stance is hardening toward lapses in quality control even as it seeks cheaper drugs to contain health care costs

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