According to a list published by the FDA on September 10, 2013 there are 41 companies that still have not paid their 2013 GDUFA facility fee. 17 out of those 41 companies are API manufacturers. Is your API partner one of them?
ChemWerth is happy to report that the facility fees have been paid for all of our partner factories. In fact, ChemWerth has actively managed this process to ensure our manufacturing partners were in compliance so our projects didn’t experience any unnecessary delay.
What You Need to Know
Payment was due no later than March 4, 2013. The FDA will not accept any new ANDAS or PASs referencing facilities that have not paid their annual GDUFA fee. So, failure to pay this fee will suspend your projects indefinitely. Also keep in mind, there is a particular sense of urgency in the generic drug industry with the impending ICH Stability Guidelines implementation. Keeping your projects moving forward is more crucial now than ever. A delay will cost you precious time to market and a significant amount of dollars.
How We Can Help
Team up with ChemWerth as your dedicated API supplier. ChemWerth is a secure and financially stable partner that is going to follow through on commitments assuring your projects get done right the first time so you don’t have to worry. Call my direct line 203-392-0467 or visit our website to review our list of commercially available APIs.