ANI Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in the development, manufacture and marketing of generic and branded prescription pharmaceuticals. With a focus on injectable and oral dosage forms, ANI delivers high-quality products to hospitals, specialty pharmacies and retail outlets. The company’s product portfolio includes a range of sterile injectables, oral solids, powders, semi-solids and liquids, addressing therapeutic areas such as oncology, anti-infectives, pain management and hospital critical care.
ANI operates multiple, FDA-inspected manufacturing facilities across the United States, each equipped for complex sterile and non-sterile production. These sites feature integrated chemistry, formulation development and analytical testing capabilities, enabling end-to-end control over product quality. Through continuous investment in process optimization, the company has expanded its capacity to meet growing demand for high-value generic injectables and specialty oral medications.
In addition to internal development, ANI collaborates with partners on co-development and licensing agreements, enhancing its access to niche markets and therapeutic segments. The company’s commercial organization supports product launches and lifecycle management, while a dedicated supply chain team ensures reliable distribution throughout North America. ANI’s global reach extends through distribution partnerships in select international markets, supporting patients and healthcare providers with timely access to essential therapies.
Founded in the mid-20th century, ANI Pharmaceuticals has evolved from a regional manufacturer to a diversified specialty pharma provider. Under the leadership of President and Chief Executive Officer Vincent A. Milone, the company emphasizes strategic acquisitions, operational excellence and innovation in sterile manufacturing. ANI’s commitment to quality, regulatory compliance and customer service positions it as a trusted partner in the pharmaceutical industry.
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