Generics News
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US FDA seeks inputs on its generic drug amendments
Generics | Regulatory | By BioSpectrum Bureau | 3 Comment | 04 Sep, 2012
Singapore: On July 9, 2012, the Generic Drug User Fee Amendments of 2012 (GDUFA) was enacted by the US. The Food and Dru...Read more
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Lupin gets FDA nod for generic Ortho Tri-cyclen Lo Tablets
Generics | Regulatory | By BioSpectrum Bureau | 3 Comment | 05 Jul, 2012
Mumbai: Mumbai-based pharma major Lupin's subsidiary, Lupin Pharmaceuticals, has received approval for its Norgestimate ...Read more
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FDA approves Sun Pharma's generic Prandin
Generics | Regulatory | By BioSpectrum Bureau | 0 Comment | 12 Jul, 2013
Singapore: The US Food and Drug Administration (FDA) has given its finally approval to India's Sun Pharmaceutical Indust...Read more
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Cipla, Alembic contest Indian drug pricing in court
Generics | News | By BioSpectrum Bureau | 0 Comment | 17 Jul, 2013
Singapore: Miffed at Indian government's move to slash prices of essential medicines through the new drug pricing policy...Read more
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Indian drug dealers worried about $1.69 bn old stocks
Generics | News | By BioSpectrum Bureau | 0 Comment | 02 Aug, 2013
New Delhi: Ahead of the Drug Price Control Order (DPCO) to revise drug prices that came into effect on July 29, medicine...Read more
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First generic versions of Cymbalta receive FDA nod
Generics | Regulatory | By BioSpectrum Bureau | 3 Comment | 13 Dec, 2013
Singapore: US Food and Drug Administration has approved the first generic versions of Cymbalta (duloxetine delayed-relea...Read more
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Takeda close to releasing Norovirus vaccine
Generics | News | By BioSpectrum Bureau | 0 Comment | 08 Jul, 2013
Singapore: Japan's drug major Takeda Pharmaceutical has said that they are set to finish the early stage human studies o...Read more
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Daiichi Sankyo's subsidiary launches four new generic drugs
Generics | News | By BioSpectrum Bureau | 0 Comment | 18 Jun, 2015
Daiichi Sankyo Company Limited has announced that on Friday, June 19, its generics subsidiary, Daiichi Sankyo Espha, wil...Read more
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US FDA extends timeline for generic drug approval
Generics | News | By BioSpectrum Bureau | 0 Comment | 29 Oct, 2012
Singapore: In a recent move, the US Food and Drug Administration (FDA) has decided to extend the timeline for granting t...Read more
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FDA approves generic versions of Plavix
Generics | Regulatory | By BioSpectrum Bureau | 0 Comment | 18 May, 2012
Singapore: The US Food and Drug Administration has approved generic versions of the blood thinning drug Plavix (clopidog...Read more
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FDA finds hair from human arm in Ranbaxy drugs
Generics | News | By BioSpectrum Bureau | 0 Comment | 19 Sep, 2013
Singapore: The US FDA released a set of further current good manufacturing practices (cGMP) violations that have been no...Read more
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TWi Pharma launches generic version of appetite loss drug
Generics | News | By BioSpectrum Bureau | 0 Comment | 29 Jul, 2015
Singapore: Taiwan based TWi Pharmaceuticals, has launched generic version of Par Pharmaceutical's Megace ES (megestrol a...Read more
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Trans-Pacific trade talks reach stalemate over IP rights
Generics | News | By BioSpectrum Bureau | 0 Comment | 23 Jul, 2013
Singapore: What started as an effort to lower trade barriers across 12 Pacific Rim nations, from the US and Canada to Vi...Read more
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Activists challenge Gilead to give up Hep C drug patent
Generics | News | By BioSpectrum Bureau | 0 Comment | 21 May, 2015
Singapore: Initiative for Medicines, Access & Knowledge (I-MAK), a team of lawyers and scientists campaigning for gl...Read more
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Teva, Sun to pay $2.15 bn to Pfizer, Takeda to settle patent suit
Generics | News | By BioSpectrum Bureau | 0 Comment | 13 Jun, 2013
Singapore: Teva Pharmaceuticals Industries, Israel, and Sun Pharmaceutical Industries, India, are going to pay a combine...Read more
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Daiichi Sankyo collaborates with Maruishi Pharmaceutical
Generics | News | By BioSpectrum Bureau | 0 Comment | 23 Jun, 2015
Japan's Daiichi Sankyo Company and Maruishi Pharmaceutical Co. Ltd have signed an agreement to collaborate on the commer...Read more
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Teva to uphold Copaxone patent until May 2015
Generics | News | By BioSpectrum Bureau | 0 Comment | 31 Jul, 2013
Singapore: Israel-based Teva Pharmaceuticals has recieved favourable response in England and Wales regarding the validit...Read more
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Pricing revision to cost Indian pharma $160 mn
Generics | Analysis | By BioSpectrum Bureau | 2 Comment | 25 Jun, 2013
Mumbai: The pharmaceutical industry will be widely impacted after India's National Pharmaceutical Pricing Authority (NPP...Read more
