Generics

twi-guanfacine-hydrochloride-abbreviated-new-drug-application-anda-gets-fda-approval

TWi Pharma gets FDA nod for ADHD drug

  • Taiwan
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  • News

Singapore: Taiwan-based TWi Pharmaceuticals has received tentative approval for its Abbreviated New Drug Application (ANDA) for Guanfacine Hydrochloride extended release tablets 1mg, 2mg, 3mg and 4mg from the US FDA. Guanfacine Hydrochloride... Read more

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Gulf nations woo Indian generic firms


  • India
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  • News
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  • By BioSpectrum Bureau
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Singapore: A new report by investment bank Alpen Capital titled, 'The GCC pharmaceutical Outlook', a number of Gulf Cooperation... Read more

dr

DRL launches Alchemia thrombosis generic in India


  • India
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  • News
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  • By BioSpectrum Bureau
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  • 0 Comment

Singapore: Alchemia's commercialization partner Dr Reddy's Laboratories has launched Alchemia's FDA approved generic anti-coagulant... Read more

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Dr. Reddy's launches generic of Singulair oral granules

  • India
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  • News
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  • By BioSpectrum Bureau
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  • 0 Comment

Bangalore: India-based Dr. Reddy's Laboratories has launched its montelukast sodium oral granules, a bioequivalent generic version of Singulair... Read more

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Bayer plea for stay on compulsory license dismissed

  • India
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  • News
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  • By BioSpectrum Bureau
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  • 0 Comment

Bangalore: The Intellectual Property Appellate Board in Chennai, India, has rejected pharma major Bayer's petition seeking a stay on compulsory... Read more

aurobindo-pharma-gets-fda-approval-for-anti-depression-generic-drug-escitalopram-oxalate

Aurobindo gets FDA nod for anti-depression generic

  • India
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  • News
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  • By BioSpectrum Bureau
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  • 0 Comment

Singapore: India's Aurobindo Pharma received final approval from the US FDA to manufacture and market Escitalopram Oxalate tablets 5mg,... Read more

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Pfizer, Hisun launch generics joint venture in China

  • China
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  • News
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  • By BioSpectrum Bureau
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  • 0 Comment

Singapore: Pfizer and China's Zhejiang Hisun Pharmaceuticals, a leading Chinese pharmaceutical company, announced the launch of Hisun-Pfizer... Read more

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Blogger sued by pharma firm for the first time in India

  • India
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  • News
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  • By BioSpectrum Bureau
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  • 1 Comment

Mumbai: NATCO Pharma has filed a lawsuit against Mr Shamnaad Basheer, professor, West Bengal National University of Juridical Sciences,... Read more

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Cipla wins patent case against Roche

  • India
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  • News
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  • By BioSpectrum Bureau
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  • 0 Comment

Bangalore: India's generics giant Cipla has won a landmark patent case against Swiss drug maker Roche in the Delhi High Court. Roche had... Read more

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Pfizer, Mylan settle litigation over Detrol LA generic

  • US
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  • News
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  • By BioSpectrum Bureau
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  • 0 Comment

Singapore: Pfizer has settled its litigation against Mylan and Mylan Pharmaceuticals relating to Pfizer's patents covering Detrol LA (tolterodine... Read more

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US FDA seeks inputs on its generic drug amendments

  • US
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  • Regulatory
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  • By BioSpectrum Bureau
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  • 1 Comment

Singapore: On July 9, 2012, the Generic Drug User Fee Amendments of 2012 (GDUFA) was enacted by the US. The Food and Drug Administration... Read more

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Novartis case hearing against Indian patent office on Sept 11

  • India
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  • News
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  • By BioSpectrum Bureau
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  • 0 Comment

Bangalore: The Supreme Court will take up the landmark case involving swiss drugmaker Novartis and India's patent office on September 11,... Read more

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