FDA Drug establishment  registration renewal  2020   calendar year    will begin   from 1st October, 2019.  Drug establishments which are registered in the year  2019 must  renew the registration  between 1st October  to 31st Decemebr 2019 in order to avoid expiration of  drug  establishment registration.

For establishments  submitted  their   initial, updated or annual registration  between  1st October to  31st  Decemebr 2019 , it is considered registered until 31st Decemebr  2020.

What information is required for drug establishment registration renewal  ?

Additional information is not required for registration renewal, you must notify if there are any changes to previously submitted registration.   You must verify , the contact person name, email and address to make sure that all the information is up to date.

FDA does not charge fee   for establishment registration or drug establishment registration renewal in the subsequent  years.

If you fail to renew the registration before  deadline published by the FDA, such establishments will be removed from FDA’s drug establishment   registration database. Also,  the drug listings  in which  such  establishments  are   referred   may  get deactivated.

We offer assistance for Drug establishment renewal at lowest fee. It will take two working days to complete the renewal process.  if you have any questions, contact us.