Our assets include 12 New Drug Applications (NDAs) for Amoxil, Augmentin, Augmentin XR and Augmentin ES-600. Each of these are FDA approved for extended or immediate release. Dosage forms consist of tablets, chewable tablets, capsules and powders for oral suspension.
Our 394,000 square foot production plant houses state-of-the-art quality control facilities, pilot scale production and HDPE bottle manufacturing. And it includes a full complement of production capabilities—from weighing, blending, drying and dry granulations/sieving, to tableting, aqueous coating and encapsulation, as well as bottle and blister packaging with serialization for DSCSA (Drug Supply Chain Safety Act) compliance.
To ensure the quality of our products, we strictly follow the FDA’s current Good Manufacturing Practice (cGMP) regulations, which outline requirements for the methods, facilities and controls used in manufacturing, processing and packing of drug products. These regulations make sure products are safe for use and that they have the ingredients and strength they claim to have. We likewise adhere to strict COVID-19 protocols for public health and safety.
Hosting routine U.S. FDA and international regulatory inspections, our facility has a stellar compliance history with regulatory agencies globally.