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New rules for Indian generic drug makers

All generic drug makers, including Ranbaxy Laboratories, Cipla, Dr Reddy's Laboratories and Lupin, are now required to pay a fee to the US drug regulator while seeking permission to launch their......
  Web results for Pdufa
BioMarin Announces Second Quarter 2015 Financial Results and Company Update

- In First Six Months of 2015 Vimizim Sales Top $104 million and Total BioMarin Revenue Grows 32% Y/Y - First Patients Enrolled in 4th Cohort of... ...

http://www.bizwireexpress.com/showstoryGNW.php?storyid=82289
Dr Reddy's domestic business strategy pays rich dividends

The first quarter of the current financial year has brought cheer to pharma major Dr Reddy's Laboratories Ltd as its growth story in the domestic... ...

http://www.thehindubusinessline.com/companies/dr-reddys-domestic-business-strategy-pays-rich-dividends/article7496172.ece?utm_source=RSS_Feed&utm_medium=RSS&utm_campaign=RSS_Syndication
ADMA Biologics seeks US FDA marketing nod for RI-002 to treat primary immunodeficiency

ADMA Biologics, Inc., a late-stage biopharmaceutical company that develops, manufactures and intends to commercialise specialty plasma-based... ...

http://www.pharmabiz.com/NewsDetails.aspx?aid=89794&sid=2
US FDA accepts for review OPKO's NDA for Rayaldee

The US Food and Drug Administration (FDA) has accepted for review OPKO's New Drug Application (NDA) for calcifediol modified-release capsules... ...

http://www.pharmabiz.com/NewsDetails.aspx?aid=89733&sid=2
ZS Pharma Announces FDA Acceptance of ZS-9 New Drug Application

GlobeNewswire 2015-07-29 PDUFA date May 26, 2016 REDWOOD CITY, Calif., July 29, 2015 (GLOBE NEWSWIRE) -- ZS Pharma, Inc. (Nasdaq:ZSPH), today... ...

http://www.bizwireexpress.com/showstoryGNW.php?storyid=78571

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