Pharma Tips

US FDA trusts Indian GMP

By: Pharma News | Views: 1478 | Date: 07-Aug-2013

The United States Food and Drug Administration (USFDA), which is considered to be the most stringent authority Indian drug makers, have been following Good Manufacturing Practices, which is clear as per the continued rate of India’s generic export to the US. The FDA believes that many companies understand and have successfully implemented good manufacturing practices and also that appropriate action would definitely be taken, should there be any non compliance observed.

USFDA trusts Indian GMP

USFDA inspection
The United States Food and Drug Administration (USFDA), which is considered to be the most stringent authority Indian drug makers, have been following Good Manufacturing Practices, which is clear as per the continued rate of India’s generic export to the US. The FDA believes that many companies understand and have successfully implemented good manufacturing practices and also that appropriate action would definitely be taken, should there be any non compliance observed.

According to the new Food and Drug Administration Safety and Innovation Act (FDASIA) - Generic Drug User Fee Amendments (GDUFA), the FDA needs to achieve the same inspection schedule for foreign facilities as domestic manufacturers. They will also have to clear of all the pending applications by the end of the first five-year user fee authorization period. They may consider having additional inspectors for the same as it will help in meeting the legislative mandates.

The FDA aims at converting from a domestically focused agency to a global health agency as trade and product performance understand no borders. With this in view, there are offices and post being opened across the globe and even in India.
Previous Page Next Page

People Searching On This Page:
  • usfda
  • Indian pharma company receives US FDA

Related Pages


Modi's industry conference in US to attract pharma, IT players

Modi's industry conference in US to attract pharma, IT players

News
Date:
02-Sep-2014  Views: 2148

Prime Minister Narendra Modi will address Indian and American industry through video conferencing during his visit to the USlater this month. The inte ...
Zydus Cadila Gets USFDA Nod for Kidney Stones Tablets

Zydus Cadila Gets USFDA Nod for Kidney Stones Tablets

News | FDA
Date:
14-Aug-2014  Views: 1675

Drug firm Zydus Cadila has received the final approval from the US health regulator to market Potassium Citrate ER tablets used in prevention of kidne ...
Ranbaxy gets FDA approval to sell generic Diovan tablets in US

Ranbaxy gets FDA approval to sell generic Diovan tablets in US

News | FDA
Date:
27-Jun-2014  Views: 1612

Drug major Ranbaxy Laboratories has received US health regulator's approval to market generic version of Novartis' Diovan tablets, used for treating h ...
USFDA warns Indian drug makers to comply with GMP standards

USFDA warns Indian drug makers to comply with GMP standards

News | FDA
Date:
05-Aug-2013  Views: 1909

USFDA states that they find contaminants like filth, pesticides and insect parts in drugs manufactured in many countries including India. FDA aims at ...
Use & Abuse of Pain Killers : Focus on Methadone

Use & Abuse of Pain Killers : Focus on Methadone

Articles | Clinical Research | Clinical Case Study
Date:
27-Jul-2013  Views: 1377

Prescription painkiller overdoses were responsible for more than 15,500 deaths in 2009. While all prescription painkillers have contributed to an incr ...
Post Your Comments (No Login Require)
Name : (required)
Email : (required)
Website :

Comment : (required)

76  + 3 =     
Comments
JB  |  10-Aug-2013 21:55:04 IST
What about this news? | FDA Date: 05-Aug-2013 Views: 880
USFDA states that they find contaminants like filth, pesticides and insect parts in drugs manufactured in many countries including India. FDA aims at ensuring that manufacturing facilities in India that import drugs to the US understand the risks associated with their product's processes and want an assurance that the drug companies will remain compliant to FDA's regulations.
People Searched About:
Usfda   |   Indian Pharma Company Receives US FDA   |  
Google : 221 times | Yahoo : 20 times | Bing : 47 times |