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About 105 results for "gdufa"

Granules gains 5% on removal from list of arrears by USFDA

Granules today said all annual facility fees as required under GDUFA, was paid before due date. Money Control, 3 weeks ago

BPTF Calls for Changes to GDUFA

The Bulk Pharmaceuticals Task Force (BPTF), an affiliate of the Society of Chemical Manufacturers and Affiliates, asked FDA at a June 15 public meeting to consider several changes to performance goals and the fee payment schedule prior to ...
 PharmTech.com1 month ago BPTF Seeks Changes in Performance Goals, Fee Payment Schedule in GDUFA Renegotiations  MoneyShow.com1 month ago

FDA Tightens Screws on GDUFA Fee Scofflaws

The FDA has warned three generics makers for failing to pay GDUFA fees during the last three fiscal years. The companies —Syntho Pharmaceuticals of Farmingdale, N.Y., Sharon Bio-Medicine of Dehradun, Uttarakhand in India, and Wuxi Kaili ...
 FDA News3 weeks ago FDA, Generic Manufacturers Want Faster GDUFA Approvals  FDA News1 month ago Generics Industry Calls for Changes to GDUFA  PharmExec.com1 month ago Generic Drug User FeeAbbreviated New Drug Application, Prior Approval Supplement, Drug Master File, Final Dosage Form Facility, and Active...  Pharmacy Choice1 day ago
Pharma Letter

Feature: Indian pharma cos seek faster clearance as GDUFA I nears end

Indian pharma companies may finally be looking at a better rate of clearances from the US Food and Drug… In order to access this content you need to be logged into the site and have an active subscription or trial subscription. Please login , ...
 Pharma Letter1 week ago Drug firms bank on faster US approvals  Calcutta Telegraph1 month ago

US generic drugmakers note shortfalls in FDA implementation of GDUFA

In a statement by Ralph Neas, president and chief executive of the US trade group the Generic Pharmaceutical… In order to access this content you need to be logged into the site and have an active subscription or trial subscription. Please login ...
 Pharma Letter1 month ago Statement by Ralph G. Neas, President and CEO, GPhA on the June 15th FDA Public Meeting on GDUFA  FirstWord Pharma1 month ago
Financial Express

BSE Sensex surges 409 points led by banking, pharma stocks; NSE Nifty above 8,500

The benchmark BSE Sensex , NSE Nifty opened in green on Friday, thereby continuing Thursday's winning streak despite mixed global trends today. (Express Photo) The benchmark BSE Sensex rocketed 409 points at 28,114.56 on Friday on continued ...
 Financial Express4 days ago BSE Sensex ends 142 points up, Dr Reddy's stocks surge nearly 6%; NSE Nifty below 8,450  Financial Express5 days ago BSE Sensex ends 43.19 points down at 28,420.12; NSE Nifty reclaims 8,600  Financial Express2 weeks ago Live: Sensex recovers 87.74 points to end at 27,661.40  Livemint.com3 weeks ago

Roth Capital: Time To Buy IGI Labs, 2016 Could Be 'Breakout Year'

In a report published Friday, Roth Capital Partners analyst Scott R. Henry upgraded the rating on IGI Laboratories, Inc. (NYSE: IG) from Neutral to Buy, while raising the price target from $7 to $11. Analyst Scott R Henry cited "stabilization of ...
 Benzinga.com1 week ago

IGI Laboratories' (IG) CEO Jason Grenfell Gardner on Q2 2015 Results - Earnings Call Transcript

Operator Good afternoon, and welcome to the IGI Laboratories Inc. second quarter 2015 results conference call. [Operator Instructions] Except for historical artifacts, the statements in this presentation as well as oral statements or other ...
 Seeking Alpha1 week ago

Pharma Packaging Solutions Opens State-of-the-Art Facility in Clinton, TN

/PRNewswire/ -- Pharma Packaging Solutions , a leading turn-key contract packager and folding carton company, is pleased to announce that their new Clinton, TN facility is now fully operational. Located seven miles from their previous Norris, TN ...
 Wall Street Business Network1 week ago
Financial Express

Greek key ignites Indian stocks

According to provisional data from stock exchanges, foreign portfolio investors (FPIs) net bought $83.13 million (Rs 527.98 crore) of shares in the cash segment. (PTI) Benchmark indices rose for the second day, gaining more than 1% on Monday, as ...
 Financial Express3 weeks ago
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