The Food and Drug Administration (FDA) has successfully inspected Nexus Pharmaceuticals’ pharmaceutical manufacturing facility located in Pleasant Prairie, Wisconsin, US.
The inspection will allow the company to commence commercial operations at the three-storey, 84,000ft² manufacturing facility.
Nexus Pharmaceuticals stated that the regulatory approval process validates facilities’ compliance with stringent quality and safety standards.
Equipped with advanced isolator technology, the Pleasant Prairie facility adheres to the highest current good manufacturing practice (CGMP) standards.
It is designed to manufacture a broad range of injectable medications and will provide hospitals and clinicians access to affordable, safe, and critical-need medicines.
Nexus Pharmaceuticals President and CEO Usman Ahmed said: “We are thrilled to receive the EIR for our Pleasant Prairie facility.
“This is a major milestone for our company and reflects our commitments to reshoring sterile pharmaceutical manufacturing to the US.
“We are proud of our team’s hard work and focus on achieving a successful inspection.
“This accomplishment is a testament to the expertise and dedication of our employees and our commitment to providing the highest quality medication to our customers.”
The Pleasant Prairie facility was opened in 2021, with an estimated investment of $100m. It comprises manufacturing space, packaging capabilities, warehousing, as well as analytical, environmental, and microbial testing.
The company intends to produce several New Drug Applications (NDAs) and Abbreviated New Drug Application (ANDAs) from the facility to provide novel products and supply chain durability to the healthcare system in the US.
It is specialised in innovative processes for producing difficult-to-manufacture speciality and generic drugs.