ALKERMES, INC.

ALKERMES, INC. specializes in the manufacturing of pharmaceutical preparations, with a focus on the development and production of complex drug formulations, including hematological and specialty therapeutics. The company possesses deep technical expertise in aseptic processing, formulation science, and quality systems compliant with cGMP standards, ensuring consistent production of high-purity pharmaceutical products for regulated markets. Their capabilities include end-to-end manufacturing of injectables and oral solids, with rigorous process validation and analytical characterization to meet FDA and VA requirements. A key differentiator is their ability to scale niche pharmaceuticals for specialized clinical needs, particularly in areas requiring precise dosing and stability control. The contractor has delivered pharmaceutical products to the Department of Veterans Affairs under a Federal Supply Schedule contract, indicating a proven track record in supplying mission-critical drugs to federal healthcare systems. This relationship suggests alignment with VA’s requirements for reliable, high-quality pharmaceutical procurement, particularly in areas such as oncology, hematology, and chronic disease management. ALKERMES operates within NAICS 325412, which encompasses the manufacturing of finished pharmaceutical preparations from active ingredients. Their market positioning centers on the production of specialty therapeutics requiring advanced formulation technologies, serving government healthcare providers that demand strict adherence to pharmacopeial standards and batch traceability. The company’s focus is narrow but highly specialized, targeting complex drug products not easily sourced through generic manufacturers. ALKERMES, INC. is a privately held entity headquartered in Waltham, Massachusetts, with no disclosed federal certifications. The company’s operational footprint is centered in the northeastern U.S., leveraging its location to support federal pharmaceutical supply chains with timely, compliant manufacturing. While not certified under small business programs, its expertise in regulated pharmaceutical production positions it as a trusted supplier to federal health agencies requiring validated, high-integrity drug manufacturing capabilities.