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[1 Nov 2011 | No Comment | ]

Sun Pharma announced that USFDA has granted its subsidiary an approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Cardizem CD, Diltiazem HCl extended-release capsules are indicated in the treatment of hypertension, for the management of chronic stable angina and angina due to coronary artery spasm.

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[10 Jun 2011 | No Comment | ]

GlenmarkGenerics Inc USA, the subsidiary of Glenmark Generics Limited, said it received final approval from the US health regulator United States Food and Drugs Administration (USFDA) for its generic Mupirocin ointment, used for the treatment of bacterial skin infections, said the company. Glenmark Generics Inc has been granted a final abbreviated new drug approval (ANDA) from the USFDA for Mupirocin Ointment USP 2 per cent, the company said.

Based on IMS Health sales data for the 12 month period ending March 2011, mupirocin ointment garnered annual sales of USD 55 million …

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[23 Mar 2011 | No Comment | ]

Jyothy Laboratories’ subsidiary Jyothy Fabricare Services Limited (JFSL) has acquired 100% stake in Delhi-based laundry player Diamond Fabcare Private Limited (DFPL), the company said in a filing to the Bombay Stock Exchange.

Featured, Pharma »

[23 Mar 2011 | No Comment | ]

Glenmark Generics Inc., USA, a subsidiary of Glenmark Generics Ltd, announced they have been granted final approval for their abbreviated new drug application (ANDA) by the United States Food and Drug Administration (USFDA) for Norethindrone and Ethinyl Estradiol, USP 0.4 mg/0.035 mg tablets, their generic version of Ovcon 35 tablets by Warner Chilcott, Inc.

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[3 Feb 2011 | No Comment | ]

Mr Pawan Chaudhary CMD Venus Remedies said, “Venus is all set to capture substantial market share by entering the highly lucrative market of Europe as it stands amongst the first few to receive the Market Authorisation for Gemcitabine”. Gemcitabine is a $1.5 billion drug world wide with more than 30% market share from Europe.

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[22 Jan 2011 | No Comment | ]

Pharma and biotechnology major Wockhardt said it has received final approval from the US health regulator—US Food and Drug Administration—to market 20 mg and 40 mg generic pantoprazole (Protonix) tablets, which are used for treating ulcers and hyperacidity, in the US market.

Featured, News, Pharma »

[25 Dec 2010 | No Comment | ]

Glenmark Generics Inc, USA, the United States subsidiary of Glenmark Generics announced that the company received approval for three abbreviated new drug application (ANDA) by the United States ood and Drug Administration (USFDA), the company informed the Bombay Stock Exchange (BSE).
Final ANDA approvals were received for Indomethacin 25 mg and 50 mg capsules, USP and Sulfamethoxazole and Trimethoprim double and single strength tablets. These products are currently available and the company has commenced shipping from their New Jersey facility. According to IMS Health, total sales achieved for the 12-month period …

Featured, News, Pharma »

[11 Dec 2010 | No Comment | ]

Venus Remedies announced the successful completion of Phase III clinical trial of a novel aminoglycoside molecule, Etimicin sulphate. Etimicin sulphate, for which Venus owns the exclusive manufacturing and marketing rights in India, was licensed from a company in China in 2007.

Featured, News, Pharma »

[8 Dec 2010 | No Comment | ]

Aurobindo Pharma has received tentative approval from the US Food and Drug Administration to manufacture and market Duloxetine Hydrochloride delayed release capsules.

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[24 Jul 2010 | No Comment | ]
USFDA gives nod for Glenmark Generics’ Norethindrone contraceptive tablets

Glenmark Generics Inc., USA, a subsidiary of Glenmark Generics Ltd, has been granted final approval by the United States Food and Drug Administration (USFDA) for Norethindrone tablets 0.35mg, the drug maker’s generic version of Micronor tablets by Ortho McNeil Janssen Pharmaceuticals, Inc.