Key Developments: Lupin Ltd (LUPN.NS)

LUPN.NS on National Stock Exchange of India

1,838.15INR
5 Mar 2015
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Latest Key Developments (Source: Significant Developments)

Lupin Ltd says FDA raises concerns over plant at Pithampur - Reuters
Monday, 23 Feb 2015 05:33am EST 

Lupin Ltd:The U.S. Food and Drug Administration (FDA) has raised concerns over production processes at a plant that makes oral contraceptives operated by Lupin Ltd - Reuters.The FDA inspected the plant in Jan., after which it issued the company a so-called Form 483, listing six observations on the manufacturing processes at the plant.Lupin didn't disclose the nature of the observations.  Full Article

Lupin Ltd receives US FDA approval for generic lumigan ophthalmic solution
Monday, 23 Feb 2015 03:24am EST 

Lupin Ltd:Says received final US FDA approval for bimatoprost ophthalmic solution 0.03.Solution is indicated for reduction of elevated intraocular pressure in patients with open angle glaucoma.  Full Article

Lupin Ltd and Celon announce strategic development and licensing agreement for Generic Advair Diskus
Tuesday, 17 Feb 2015 06:36am EST 

Lupin Ltd and Celon Pharma S.A.;:Says both entered into definitive agreement under which companies will jointly develop fluticasone/salmeterol dry powder inhaler (DPI) product which is generic version of GlaxoSmithKline's Advair Diskus.Lupin will be responsible for commercialization of product.Celon will supply product to Lupin for its commercialization in US, Canada, Mexico, and other key markets.GlaxoSmithKline's Advair Diskus had global sales of over $7 bln as of last fiscal.  Full Article

Lupin Ltd gets USFDA approval for diarrhoea drug-Business Standard
Tuesday, 3 Feb 2015 04:30am EST 

Lupin Ltd:Received approval from the US health regulator to sell a generic version of Vancocin capsules, used in treating diarrhoea, in the American market-Business Standard.The company has received final approval for its Vancomycin Hydrochloride Capsules in strengths of 125 mg and 250 mg from the US Food and Drugs Administration (FDA) to market a generic version of ANI Pharmaceuticals, Inc's Vancocin, Lupin Ltd said.  Full Article

Lupin Ltd launches generic Diovan tablets-Business Standard
Tuesday, 6 Jan 2015 05:36am EST 

Lupin Ltd:Has launched generic version of Diovan tablets, a hypertension drug, in the US market after getting approval from the American health regulator-Business Standard.  Full Article

Lupin Ltd receives tentative approval for generic prezista tablets
Tuesday, 30 Dec 2014 05:49am EST 

Lupin Ltd:Receives tentative approval for its darunavir ethanolate tablets from FDA to market a generic version of janssen products, LP prezista tablets.  Full Article

Lupin Ltd gets USFDA approval for HIV drug-Business Standard
Friday, 26 Dec 2014 05:30am EST 

Lupin Ltd:Has received US health regulator's approval to market a generic version of ViiV Healthcare's Epivir Tablets, used in treating HIV infection, in the American market-Business Standard.  Full Article

Lupin Ltd launches authorized generic for Celebrex Capsules
Thursday, 11 Dec 2014 02:00am EST 

Lupin Ltd:Says a US subsidiary, Lupin Pharmaceuticals Inc has launched the authorized generic for G.D. Searle LLC’s Celebrex Capsules 50 mg, 100 mg, 200 mg and 400 mg strengths.Lupin had earlier signed a licensing agreement with Pfizer Inc regarding Celebrex.  Full Article

Lupin Ltd receives FDA approval for generic celebrex capsules
Monday, 3 Nov 2014 01:09am EST 

Lupin Ltd:Says it has received final approval for its celecoxib capsules, 50 mg from the united states food and drugs administration to market a generic version of G.D. Searle LLC's celebrex capsules 50 mg.Says Lupin also received tentative approvals for its celecoxib capsules 100 mg, 200 mg and 400 mg strengths from the FDA.  Full Article

Lupin Ltd completes acquisition
Wednesday, 1 Oct 2014 09:50am EDT 

Lupin Ltd:Refers to the earlier letter dated March 27 informing about the acquisition of 100 pct equity stake in Laboratorios Grin, S.A. DE C.V., Mexico.Says the closing conditions of the said acquisition were completed on Sept. 30.Consequent to which, Lab Grin has become a wholly-owned subsidiary of the company from Sept. 30.  Full Article

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India's Lupin says FDA raises concerns over plant at Pithampur

MUMBAI - The U.S. Food and Drug Administration (FDA) has raised concerns over production processes at a plant that makes oral contraceptives operated by Lupin Ltd, India's fourth-largest generic drug manufacturer by sales.

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