Page 9 - Glenmark Pharmaceuticals

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 ...

Glenmark Pharma gets final USFDA nod for menopause symptom relief drug

The approved product is a generic version of Novo Nordisk Inc's VAGIFEM

Glenmark to boost cash flows, pare debt as it eyes a lighter balance sheet

Pharma major is monetising assets through licensing arrangements, restructuring operations

Glenmark in deal with Chinese firm Harbour BioMed for innovative molecule

With a stringent regulatory environment in China, not many Indian companies have been able to conduct clinical trials in that market

Glenmark Pharmaceuticals to file appeal before NCLAT against CCI penalties

Drug firm Glenmark Pharmaceuticals today said it will file an appeal against the order of the Competition Commission of India (CCI) before the National Company Law Appellate Tribunal. On July 13, CCI had imposed penalties totalling nearly Rs 47 crore on Glenmark Pharmaceuticals, its three officials, two other pharma companies and four Gujarat-based chemists associations for indulging in unfair business practices. Besides, a carry and forward (C&F) agent had also been penalised. M/s Reliance Medical Agency had filed a complaint with the CCI against the Chemist & Druggist Association of Baroda including pharma companies and C&F agents alleging that prior to being appointed as stockist they were required to obtain NOC from the local Chemist and Druggist Associations in Gujarat, Glenmark said in a BSE filing. "The Commission has relied on findings of the Director General and held that Glenmark is mandating no-objection certificates (NOC) from the trade associations for ...

Glenmark launches drug for chemotherapy-induced nausea in India, Nepal

The product has been developed by Swiss pharma group, Helsinn and Glenmark has exclusive marketing rights for it in India and Nepal

Glenmark's US facility to go onstream with nod for anti-malaria drug

Market size of drug is $40 mn. Having a manufacturing footprint in the US is part of company's game plan to mitigate regulatory risk

Glenmark Pharma hits 52-week low on subdued Q4 results

The stock hit a fresh 52-week low of Rs 484, slipped 9% on the BSE in early morning trade, after the company reported 17% decline in its consolidated net profit at Rs 1.52 billion in March quarter.

Glenmark recalls 100,000 bottles of drug over incorrect instrictions

The ongoing nationwide voluntary recall is a class III recall

Glenmark Pharma declines 9% on weak Q3 results

The stock fell 9% to Rs 524, its 52-week low on BSE trade after the company reported 78% fall in its consolidated net profit at Rs 1.05 billion for the quarter ended December 2017.

Expecting India, US, Europe to contribute over 80% sales by 2021: Glenmark

The company is also planning to scale up its speciality business in the US as part of its future outlook for 2021

Glenmark Pharma gets approval for inhaler product in Nordic countries

Glenmark Pharmaceuticals Europe Ltd today said it has received approval for an inhaled respiratory product in Nordic countries, including Sweden, Denmark, Norway, Finland and Iceland. The company "has successfully closed the decentralised registration procedure for generic Seretide Accuhaler in the Nordic region", Glenmark Pharma said in BSE filing. "This will be Glenmark's first inhaled respiratory product approval in Europe, and re-enforces Glenmark's commitment in the respiratory area," it said. The company added that the commercialisation of the product would depend on national approval as well as substitution and pricing approvals. Glenmark had entered into a strategic development and licensing agreement with Celon Pharma S.A. to develop and market a generic version of GlaxoSmithKline's Seretide Accuhaler product - Fluticasone / Salmeterol dry powder Inhaler in Europe. Glenmark Pharmaceuticals Chairman & MD Glenn Saldanha said: "We will continue to work in the .

Glenmark Pharma falls 3% as Baddi unit gets 7 observations from USFDA

The stock dipped 3% to Rs 574 on the BSE in intra-day trade.

Glenmark Pharma gets 7 US FDA observations for Baddi unit, to reply soon

Glenmark said its Baddi unit contributes approximately 10 per cent of the revenue of the US sales

Glenmark Pharma launches nicotine substitute gum Kwitz

Kwitz nicotine gum will be available in two variants of 2 mg as an OTC product 4mg as prescription product, the company said in a statement