AVARA | Avara Pharmaceutical Services | Arecibo Site

The facility is a large-scale, multi-product oral solid dosage (OSD) manufacturing site located in USA. The site operates from clinical to commercial scale and is DEA-approved, with extensive experience in handling controlled substances (Schedule II–V).

The site offers a broad range of OSD manufacturing capabilities, including blending, milling, dry granulation, fluid bed drying, tablet compression (including bi- and tri-layer), encapsulation (powder and pellet filling), and advanced coating technologies such as film, column, and Wurster coating. The site also provides high-speed visual inspection and supports potent compound handling.

The facility integrates end-to-end packaging operations, including bottle filling, capping, heat sealing, labeling, serialization, and automated visual inspection, ensuring compliance with global regulatory requirements.

This site features extensive infrastructure, including a large warehouse with controlled temperature storage, cold storage (2–8°C), and dedicated controlled substances vaults. The site operates within a Foreign Trade Zone and is equipped to handle hazardous materials and large-scale commercial supply chains.

The site includes two analytical laboratories (main and high-containment) offering capabilities such as method transfer, validation, development, stability studies, and full QC testing using advanced instrumentation (HPLC/UPLC, GC, FT-IR, dissolution systems).

Additionally, the facility offers significant expansion potential through a pre-commissioned GMP facility (Module 8), providing approximately 50,000 sq. ft. of flexible manufacturing space that can be customized to meet future client and technology requirements.

With a strong regulatory track record, robust infrastructure, and deep expertise in controlled substances and commercial manufacturing, the site is positioned as a reliable partner for global pharmaceutical supply.