Case Study

How an ANDA Project Overcame Unique Sourcing and Manufacturing Challenges

When the patent on a brand-name dental paste expired, our client saw an opportunity to offer sufferers of painful oral lesions a generic alternative. Their product would drive down costs for patients while positioning the client’s business for success in a competitive market. With the FDA’s Abbreviated New Drug Application (ANDA) regulatory pathway leading the way forward, all they needed was a partner with experience developing and manufacturing unique semi-solid products. That’s when they found LGM Pharma.