Key Developments: Glenmark Pharmaceuticals Ltd (GLEN.NS)

GLEN.NS on National Stock Exchange of India

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Latest Key Developments (Source: Significant Developments)

Glenmark Pharmaceuticals Ltd receives tentative ANDA approval for Calcipotriene Cream
Sunday, 3 May 2015 11:28pm EDT 

Glenmark Pharmaceuticals Ltd:Says that it has been granted tentative approval by United states Food and Drug Administration for Calcipotriene Cream, 0.005 pct, the therapeutic equivalent of Dovonex Topical cream, 0.005 pct of Leo Pharma A/S.Says it will market this product upon receiving final approval of its Calcipotriene Cream, 0.005 pct ANDA.  Full Article

Glenmark Pharmaceuticals Ltd receives ANDA approval for Levonorgestrel and Ethinyl
Friday, 10 Apr 2015 12:10am EDT 

Glenmark Pharmaceuticals Ltd:Says it has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for the oral contraceptive, Levonorgestrel/Ethinyl Estradiol Tablets USP, 0.09 mg/0.02 mg, , the therapeutic equivalent of Lybrel of Wyeth Pharmaceuticals Inc.  Full Article

Glenmark Pharmaceuticals Ltd receives approval for generic Seretide in Russia
Wednesday, 11 Mar 2015 11:48pm EDT 

Glenmark Pharmaceuticals Ltd:Announces that it has received approval for Salmecort MDI inhaler, from the Ministry of Health, Russia.Says the combination preperation contains salmeterol xinafoate and fluticasone propionate, used in the management of asthma and chronic obstructive pulmonary disease.Says the approval is for 25mcg+50mcg/dose, 25 mcg + 125 mcg/dose and 25 mcg + 250 mcg/dose formulation strengths.  Full Article

Glenmark Pharmaceuticals Ltd gets USFDA nod to sell generic blood pressure drug-Business Standard
Thursday, 26 Feb 2015 04:45am EST 

Glenmark Pharmaceuticals Ltd:Received approval from the US health regulator to sell its generic version of AbbVie Inc's blood pressure drug Tarka in the American market-Business Standard.The approval for trandolapril and verapamil hydrochloride extended release tablets has been granted to Glenmark Generics Inc, a subsidiary of Glenmark Generics Ltd.Glenmark will commence distribution of trandolapril and verapamil hydrochloride tablets immediately.Tarka is indicated for treatment of hypertension.  Full Article

Glenmark Pharmaceuticals Ltd gets USFDA nod for generic contraceptive tablets-Business Standard
Thursday, 26 Feb 2015 02:54am EST 

Glenmark Pharmaceuticals Ltd:Received approval from the US health regulator for generic Ashlyna contraceptive tablets and launched them in the American market-Business Standard.Glenmark Generics Inc USA, announced the US market approval and introduction of Ashlyna extended-cycle oral contraceptive tablets, Glenmark Pharmaceuticals said in a statement.The tablets are generic equivalent of Teva Women's Health's Seasonique tablets.The company plans to commence shipping of Ashlyna immediately.  Full Article

Glenmark Pharmaceuticals Ltd's TRPA1 antagonist GRC 17536 shows positive data
Wednesday, 17 Sep 2014 04:11am EDT 

Glenmark Pharmaceuticals Ltd:Says its first in class Transient Receptor Potential Ankyrin 1 (TRPA1) antagonist, GRC 17536 has shown positive data in a Phase 2a double blind, placebo controlled, multi-centre, proof of concept study conducted on 138 patients in Europe and India.A statistically significant and clinically relevant response was seen in a prospectively-identified, substantial sub-group of patients with moderate to severe pain who had relatively intact sensory responses as detected by a standardized testing methodology.GRC 17536 was well-tolerated with no evidence of CNS or other drug related side effects.  Full Article

Glenmark Pharmaceuticals enters Oncology with discovery and initation of IND enabling studies of bispecific antibody
Tuesday, 19 Aug 2014 11:18pm EDT 

Glenmark Pharmaceuticals S.A:Says discovery and initiation of IND enabling studies of a novel clinical development candidate, GBR 1302, a HER2xCD3 bispecfic antibody.GBR 1302 is first clinical development candidate based on BEAT technology.Expects approval for initiation of clinical studies during this financial year.  Full Article

Glenmark Pharmaceuticals Ltd to set up a new manufacturing facility
Thursday, 17 Jul 2014 04:59am EDT 

Glenmark Pharmaceuticals Ltd:Plans to set up a new manufacturing facility in the US.The company plans to set up this manufacturing facility at Monroe Corporate Center, North Carolina, USA.The facility will be spread over 100,000 sq. feet (around 15 acre plot).It will first begin work on an oral solid unit and thereafter set up manufacturing units for injectables and topicals.  Full Article

Glenmark Pharmaceuticals Ltd's Glenmark Generics Inc, USA receives final ANDA approval for Fluocinonide cream
Tuesday, 15 Jul 2014 12:53am EDT 

Glenmark Pharmaceuticals Ltd:Says that Glenmark Generics Inc, USA, subsidiary of Glenmark Generics Ltd, has been granted final approval from U.S. FDA for its abbreviated new drug application (ANDA) for Fluocinonide Cream USP 0.1 pct., generic version of Vanos Cream by Medicis.  Full Article

Glenmark Pharmaceuticals's subsidiary receives final ANDA approval for Telmisartan Tablets
Tuesday, 8 Jul 2014 02:31am EDT 

Glenmark Pharmaceuticals Ltd:Glenmark Generics Inc., USA subsidiary of Glenmark Generics Limited has been granted final abbreviated new drug approval (ANDA) from the United States Food and Drug Administration (US FDA) for Telmisartan Tablets.Glenmark will commence distribution of product immediately.Telmisartan Tablets are Glenmark’s generic version of Boehringer Ingelheim’s Micardis.Telmisartan is indicated for treatment of hypertension.Approval is for 20mg, 40mg and 80mg tablets.For 12 month period ending March 2014, Telmisartan garnered annual sales of $250 mln according to IMS Health.  Full Article

Temasek to invest $150 mln in India's Glenmark Pharma

MUMBAI, April 17 - Singapore state investment arm Temasek will invest 9.45 billion rupees ($151.39 million) in Glenmark Pharmaceuticals Ltd through its wholly-owned subsidiary Aranda Investments, Glenmark said in a statement on Friday.

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