PAR STERILE PRODUCTS, LLC

PAR Sterile Products, LLC specializes in the manufacturing of sterile biological products excluding diagnostics, operating within the stringent regulatory framework of cGMP and FDA-compliant aseptic processing. Their technical expertise centers on sterile fill-finish operations, biologics formulation, lyophilization, and end-to-end aseptic manufacturing systems designed for parenteral delivery. The company’s capability is grounded in controlled environmental systems, sterility assurance protocols, and validated cleaning and sterilization processes essential for high-purity biological therapeutics. While limited public performance data is available, their contract under NAICS 325414 confirms direct involvement in producing non-diagnostic biological products for federal health programs, indicating proficiency in supply chain integrity, batch traceability, and regulatory documentation required for public health applications. The contractor has demonstrated engagement with the Department of Health and Human Services, primarily supporting the production and lifecycle management of biological agents used in public health initiatives. Their relationship with HHS appears focused on contract execution and administrative closeout activities, suggesting a role as a specialized manufacturer within federal biologics procurement channels. Their primary industry focus is biological product manufacturing, specifically the production of injectable therapeutics, vaccines, or other non-diagnostic biologics requiring sterile handling. This positions them within the niche of contract manufacturing for government-funded biological programs, where compliance with USP <71> and 21 CFR Part 211 is critical. PAR Sterile Products, LLC is structured as a ZZ entity based in Woodcliff Lake, New Jersey, with no publicly listed government certifications. The company operates as a single-site manufacturer with a focused footprint in the Northeast U.S., serving federal health agencies through specialized sterile manufacturing services without broad certification status. Their market positioning is that of a niche, technically precise producer within the federal biologics supply chain.