About 86 results for "gdufa"

Commerce ministry may step up MAI sops to exporters to cope wi...

In a move that could bring huge relief to the Indian exporters to the US, the commerce ministry may soon provide some incentives to support the exporters to cope up with the increasing burden of huge user fee that the US FDA has been levying from ... PharmaBiz, 2 months ago

Absorption Systems Registers with FDA as a Generic Drug Facility under GDUFA

/PRNewswire/ -- The preclinical contract research organization Absorption Systems, a global leader in pharmacokinetic testing of drugs and the world leader in the in-vitro classification of drugs according to the Biopharmaceutics Classification ...

TickerTech.com, 1 month ago Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives Public Hearing; Request for Comments Pharmacy Choice, 2 weeks ago Absorption Systems Partners With Synerzys To Promote Biopharmaceutics Classification System (BCS) Testing Of Drugs Drug Discovery Online, 3 weeks ago Generic Drug Facilities, Sites, and Organizations Pharmacy Choice, 1 month ago

More from: Los Angeles Business, Los Angeles Business...and 25 other sources

[x]

FDA Sets Fiscal 2014 GDUFA Self-Identification Deadline

, to submit self-identification information to the FDA for fiscal 2014. Those that self-identified for fiscal 2013 must self-identify again for fiscal 2014, according to a recent Federal Register notice.

FDA News, 3 weeks ago FDA Sets Fiscal 2014 GDUFA Self-Identification Deadline FDA News, 3 weeks ago FDA Sets Fiscal 2014 GDUFA Self-Identification Deadline FDA News, 1 month ago US FDA Calls on API, Generic Companies to Begin Self-Identification Process for 2014 In-Pharmatechnologist, 1 month ago

SUNPHARMA - Acquisitions to Drive the Next Growth Wave - new market research report

Sun Pharma's Q3 FY13 result was better than our estimates largely on account of stronger sales of Taro. Lipodox continued during the quarter. We expect sustainable annual sales of $80-100m for Sun's Lipodox, assuming entry of one additional generic ...

TransWorldNews, 5 days ago

Moneycontrol.com

FinQuest Securities maintains 'Hold' on Glenmark Pharma

FinQuest Securities' research report on Glenmark Pharmaceuticals " Glenmark Pharma reported strong 25.3 percent Y-o-Y increase in revenue excluding licensing income at Rs.13,355mn beating the street estimates by 3 percent and our estimates by 6 ...

Moneycontrol.com, 1 week ago Glenmark Pharmaceuticals (Q4 FY13) India Infoline, 2 weeks ago Outlook positive for pharma companies: ICRA Moneycontrol.com, 1 month ago Outlook for pharma companies positive: ICRA The Financial Chronicle, 1 month ago

More from: MyIris, Hindu Business Line...and 6 other sources

[x]

Akorn Reports First Quarter 2013 Financial Results

Akorn, Inc. (NASDAQ: AKRX), a niche generic pharmaceutical company, today reported financial results for its first quarter ended March 31, 2013. Raj Rai, Chief Executive Officer, commented, "We are pleased with our first quarter results although we ...

Stockwatch, 2 weeks ago 5/7/13 - Akorn Reports First Quarter 2013 Financial Results Pharmacy Choice, 2 weeks ago AKORN, INC.: Akorn Reports First Quarter 2013 Financial Results - Reports Record Revenue of $73.9 million and Adjusted EPS of $0.13 4 Traders, 2 weeks ago

More from: TMC Net, CNBC...and 12 other sourcesTMC Net, CNBC...and 12 other sources

[x]

Will US budget aid Indian pharma?

Posted by Equitymaster Recently, Barack Obama - the US president had presented the budget for fiscal 2014. It's a known fact that Indian pharma companies have a sizeable presence in the US pharma market. Among various proposals, one of the proposal states ...

Equitymaster.com, 1 month ago President Signs into Law Budget Bill that Restores FDA's Authority to Spend User Fees AAPS Pharmceutica, 1 month ago

FDA Oversight a Priority in Coming Year, Say House E&C GOPers

Clinical Trials Advisor Republican legislators on the House Energy & Commerce Committee are setting their sights on cutting red tape, especially at the FDA, as part of their health regulatory priorities in the 113th Congress. This article is ...

FDA News, 1 month ago

Updated Excipient Package User Guide Aims to Reduce Redundancy for Suppliers

Text size Print Forward By Zachary Brennan , 27-Mar-2013 Related tags: user guide, Jatropha, excipients, IPEC, gutter oil Related topics: Ingredients, , QA/QC As excipient suppliers are inundated with similar requests from users regarding quality ...

In-Pharmatechnologist, 1 month ago

InPharm

Two Apotex facilities cited by FDA

Canadian generic drugmaker Apotex has been sent another warning letter by the FDA after violations were uncovered at two manufacturing facilities. The warning letter says that Apotex failed to follow procedures to ensure supposedly sterile products ...

InPharm, 2 months ago