The FDA is making good on their promise. The dollars generated from GDUFA fees are funding the increased scrutiny of overseas generic drug suppliers. As a result, the quality of many finished dosage companies are making headlines, as exampled below.
Medicines Made in India Set Off Safety Worries
Article published in New York Times, February 14, 2014
The implementation of GDUFA has allowed the FDA to increase resources to inspect overseas finished dosage facilities as well as API providers. The bar has been raised for those that want to participate in key regulated markets like the US and EU and it appears this might just be the tip of the iceberg. These inspections have become a top priority for the FDA. If you haven’t already received a knock on your door, you will. It’s only a matter of time. The FDA is coming.
The Big Picture:
GDUFA’s focus on safety, accessibility and transparency in an effort to provide low cost, high quality pharmaceuticals to the US generic drug market is good for the industry. However, it will continue to be overwhelming as companies try to keep track of supplier quality, submission checklists, facility standards, increased inspections, fee obligations, and all of the other requirements involved in getting a drug to market. Businesses that can endure this paradigm shift will have a competitive advantage over those companies that struggled with acclimating or shut down for good. So, how do you do it?
Minimize your variables. Focus on your facility and let ChemWerth worry about the quality of your API and all of the back office work involved in getting the DMF Available for Reference. Within the past 12 months, ten of ChemWerth’s represented factories in China and India have been inspected by the FDA. All ten passed inspection. Six of those ten passed with zero 483s. We know how to navigate through the constantly changing guidelines and have a 31 year track record of compliance and product excellence. Our responsibility to helping our customers develop safe products for everyone in every country, makes ChemWerth the “go to” source for API supply and management with a ‘One World-One Quality’ approach that is the back bone of everything we do, every decision we make; making ChemWerth the ‘One Company’ for your API needs.