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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
Alembic Pharma Q1 net up 8%, global branded biz plunges 63%

India generics, international branded business impacted overall growth in Q1. The street had expected profit more than Rs 140 crore on revenue... ...
Indian pharma views latest norms on analytical & validation methods for drugs & biologics crucial for global audits

Indian pharma industry is now breathing a sigh of relief with the US FDA's latest guidance on the analytical procedures and methods of validation... ...
Dr Reddy’s first quarter net profit rises by 13.6%

Hyderabad Backed by growth in its key markets, drug maker Dr Reddy’s Laboratories reported a 13.6 per cent increase in its net profit for the... ...
Allergan Confirms Generic Tyvaso® Patent Challenge

Allergan plc (NYSE:AGN) Intraday Stock Chart Today : Thursday 30 July 2015 DUBLIN , July 30, 2015 /PRNewswire/ --Allergan plc (NYSE: AGN)... ...
Sofgen's Nimodipine 30mg capsule receives US FDA approval

ANI Pharmaceuticals, Inc., an integrated specialty pharmaceutical company, announced that its ANDA collaboration partner Sofgen, a specialized... ...

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