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About 73 results for "gdufa"

FDA Is Fulfilling GDUFA Commitments, Official Says

body: The Food and Drug Administration is fulfilling its negotiated Generic Drug User Fee Amendments commitments, Kathleen Uhl, director of the agency's Office of Generic Drugs, said on AAPS Pharmceutica, 1 week ago
FDA making progress with ANDA backlog GaBi Online, 2 weeks ago

Aceto's Attractive Asset Portfolio Makes It A Buy

Summary Q1 2016 presents strong earnings growth due to modest increase in revenues and sharp rise in margins. Upcoming generic product launches increase optimism for 2016, and provide for continued top-line growth. Our price target moves to ...
 Seeking Alpha1 day ago
Wall Street Select

IGI Laboratories Announces Third Quarter 2015 Results

Third Quarter 2015 Highlights Full Year 2015 Financial Guidance IGI's President and Chief Executive Officer, Jason Grenfell-Gardner On the regulatory front, we have submitted ten ANDA submissions so far this year, including today's ...
 Wall Street Select1 month ago Stephen Richardson Appointed As Chief Scientific Officer Of IGI Laboratories, Inc.  Marketplace1 month ago IGI Laboratories, Inc. Announces Ninth ANDA Submission Of 2015  Fat Pitch Financials1 month ago
European Pharmaceutical Review

CPhI report highlights potential risks in biologics supply chain outsourcing

CPhI Worldwide, organised by UBM EMEA, has announced the findings of the fourth and final section of its 2015 annual report, The Outsourcing perspective, live from CPhI Worldwide 2015 in Madrid. Four leading experts on the global pharma outsourcing ...
 European Pharmaceutical Review1 month ago
Financial Express

Pharma stocks set to pip Nifty for fifth year on drug approvals

Shares of pharmaceutical companies are poised to outperform benchmark indices for the fifth consecutive calendar year, driven by a pick-up in USFDA approvals and a weak rupee, providing a double-boost to profitability and stock performance of ...
 Financial Express1 month ago
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