PINE PHARMACEUTICALS LLC

Pine Pharmaceuticals LLC specializes in the manufacturing of sterile pharmaceutical preparations and metabolic isotopes for federal research and clinical applications, with deep expertise in GMP-compliant compounding and stable isotope synthesis. The company produces intravenous formulations of deuterated glucose and other metabolic tracers used in NIH-funded metabolic research, ensuring precise uniformity in drug composition, appearance, and packaging to meet stringent clinical trial standards. Their technical capabilities extend to the production of biological products and organic chemical intermediates, demonstrating proficiency in aseptic processing, isotopic labeling, and small-batch pharmaceutical manufacturing under 503B compounding guidelines. A key differentiator is their ability to deliver non-severable, mission-critical isotopic agents with consistent quality across extended study periods, supporting high-precision metabolic and diagnostic research. The contractor maintains a strong, sustained relationship with the Department of Health and Human Services, particularly the National Institute of Diabetes and Digestive and Kidney Diseases, providing specialized isotopic reagents and compounded pharmaceuticals for research protocols. They also serve the Department of Veterans Affairs with 503B-compounded sterile products, indicating reliable delivery of non-commercial, patient-specific formulations for clinical use in VA medical centers. Pine Pharmaceuticals operates primarily under NAICS 325412, focusing on pharmaceutical preparation manufacturing, with secondary expertise in biological product manufacturing (325414) and organic chemical synthesis (325199). Their market positioning centers on niche, research-driven pharmaceutical supply for federal science agencies, filling gaps where commercial manufacturers cannot meet specialized isotopic or compounding requirements. As a small business structured as 2K, Pine Pharmaceuticals is headquartered in Tonawanda, New York, with no federal certifications listed. Their geographic presence supports federal research and healthcare missions through direct, agile manufacturing and logistics tailored to the unique demands of government-sponsored biomedical programs.