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Abbreviated New Drug Application

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Indian drugmakers to pay higher facility fees on US hike

The US laws authorise the drug and health watchdog to assess and collect user fees for certain applications and supplements for human generic drug products Drugmakers from India, the biggest source......

US to charge fee on generic drug sale application

All generic pharmaceutical companies, including Ranbaxy Laboratories, Cipla, Dr Reddy's Laboratories, Lupin, Glenmark and Torrent Pharma, might soon have to pay a fee to the US drug regulator when......

Cipla HIV drug gets USFDA nod

Cipla has got tentative approval from the United States Food & Drug Administration for its abbreviated new drug application for anti-HIV/AIDS drug Slamivudine.According to information available on......

Lupin gets USFDA nod for Cephalexin

Lupin Ltd on Thursday said it has received USFDA approval for its Abbreviated New Drug Application for multiple strengths of antibiotic Cephalexin capsules.The approval is for Cephalexin capsules......

Zydus Cadila files 12 ANDAs in FY-04

Ahmedabad-based Zydus Cadila group has filed 12 Abbreviated New Drug Applications in fiscal 2003-04 even as the company has set a target to file 16-18 ANDAs in the current financial year.The group......
  Web results for Abbreviated New Drug Application
New drugs top Cadila Healthcare's prescription for growth

Cadila Healthcare is aiming high: it is gunning for revenues of R10,000 crore by FY 2016. India's fourth largest pharmaceutical company, and the... ...

http://www.financialexpress.com/article/companies/focus-on-innovation-new-drugs-top-cadila-healthcares-prescription-for-growth/69075/
Breckenridge Announces Approval for Repaglinide Tablets, USP

BOCA RATON, Fla. , April 29, 2015 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc. announces the final approval by the U.S. Food and Drug... ...

http://www.asianhhm.com/pressreleases/breckenridge-announces-approval-for-repaglinide-tablets-usp
TWi settles Dexilant patent litigation with Takeda

TWi Pharmaceuticals, Inc (Twi), a leading specialty pharmaceutical company, has entered into a settlement agreement with Takeda Pharmaceutical... ...

http://www.pharmabiz.com/NewsDetails.aspx?aid=87957&sid=2
AbbVie Profit Rises on Broad Sales Growth -- Update

AbbVie Inc. (NYSE:ABBV) Intraday Stock Chart Today : Friday 24 April 2015 By Peter Loftus AbbVie Inc. laid out its plans to defend its... ...

http://in.advfn.com/news_AbbVie-Profit-Rises-on-Broad-Sales-Growth-Update_66547918.html
Sun Pharma's next hurdle

Recent correction is an opportunity to add a quality stock to your portfolio, even amid uncertainty Sun Pharmaceutical Industries' stock fell 8.5... ...

http://www.rediff.com/money/report/integration-challenges-sun-pharmas-next-hurdle/20150423.htm

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