Communication is key when working together. Whether it's in person, over the phone, or through email, we are always available to answer any questions you may have. We understand that communication is a two-way street, so we also make sure to keep you updated on our process every step of the way. That way, you can rest assured that you are in good hands. Contact us today to learn more about how we can help you achieve your goals. Thank you for considering Nexus Pharmaceuticals as your partner in health care.
Contact UsA New Drug Application (NDA) is the application to the FDA that formally proposes the approval of a new pharmaceutical drug. An Abbreviated New Drug Application (ANDA) contains data that is submitted to the FDA for the review and potential approval of a generic drug product.
90% of prescriptions filled are generic.
Ready-to-use, manufacturer-prepared products are viewed as the drug delivery of choice because there is a lower risk for contamination, ease of use, and reduction in medication errors.
Aseptic Fill-Finish is a process in which the drug product, container, and container closure are first sterilized separately and then brought together.
Terminal sterilization is conducted after a drug has been manufactured and uses heat at 121º Celsius to sterilize the drug product.
Lyophilization is a freeze-drying process that removes water from a pharmaceutical product after it is frozen. This is done by placing the product under a vacuum to remove air and excess water.
cGMP stands for the Current Good Manufacturing Process. The United States FDA sets the cGMP standards and enforces the regulations. cGMP also provides guidelines for a variety of systems to assure proper design, monitoring, and control of pharmaceutical manufacturing processes and facilities
Technology transfer is the transfer of drug product and process knowledge between development and manufacturing, or between two manufacturing sites or organizations.
Parenteral drug administration is a non-oral drug or substance administered to your body internally. While there are many methods of routes, parenteral administration is done through injection (needle) bypassing the skin and mucous membranes.
Cytotoxic drugs inhibit or prevent the function of cells. Cytotoxic drugs are primarily used to treat cancer, frequently as part of a chemotherapy regime.