ABOUT THE J. MOLNER COMPANY
The J. Molner Company provides our customers with the highest level of generic drug development for sterile injectable and dermatology drugs with a focus on the U.S. and Canadian markets. We also provide our clients with analytical chemistry services and cost-saving commercial stability solutions.
We’re focused on helping our clients augment their internal resources to develop faster and get to market sooner.
IN-VITRO RELEASE TESTING
We specialize in IVRT testing, providing comprehensive support from development to post-approval changes for semisolid dosage forms throughout the product lifecycle.
POST APPROVAL CHANGE MANAGEMENT
We present a unique harmonization between our technical laboratory capabilities and specialized regulatory expertise to manage ANDA changes through the FDA, on your behalf.
We solve analytical chemistry challenges for our clients with our state-of-the art laboratory operated by an agile team.
EU MARKET RELEASE
Our laboratory team and our QP can help release your batches to the EU market quickly and efficiently.
We develop sterile injectable and dermatology drugs from concept to technical transfer.