Oral Solid Dose manufacturing

Your Product. Our Passion.

Specialized to manufacture oral solid dosage (OSD) forms, Alcami’s Wilmington, North Carolina site supports preclinical production through commercial launch and supply. We differentiate ourselves by providing ample problem-solving solutions to your scientific needs.  

Our cGMP manufacturing technologies are arranged in flexible suites designed for novel, advanced, and complex projects. Embedded within the manufacturing facility, our formulation development experts assist in product development and lifecycle management including formulation changes and qualification of additional indication with expert small volume product support with small lot sizes made as needed. Development and manufacturing of OSD products are carefully tailored for orphan drug and niche dosage forms where micro batches and flexibility in processing equipment is critical to preserving API. Alcami gives you the capability to formulate a safe, stable medicine and develop a robust manufacturing process that is scalable for your commercial supply with OSD formulations and manufacturing teams being housed in the same state-of-the-art building. We are licensed by the US DEA to manufacture Schedule 1, 2, 2N, 3, 3N, 4, 5, and L1 controlled substances. 

Hard Shell Capsules Tablets Powders
  • Powder blends
  • Neat filled drug in capsule
  • Beads in capsules
  • Minitabs in capsules
  • Over-encapsulation for clinical blinding
  • Immediate release
  • Sustained release
  • Controlled release
  • Orally disintegrating
  • Minitablets
  • Blends in bottles for reconstitution 
  • Neat API bottle fills for Phase I clinical supplies
  • Reconstitution

 

Ready to Get Started?

Connect with an Expert

 

Alcami’s overall operational excellence allows for a seamless integration of all our operations including packaging and distribution, an area made all the more critical with the advent of supply chain security initiatives by regulators. We provide custom packaging, labeling, and kitting for materials destined for global trials and markets.

Clinical phase supply is a particular area of focus. Alcami can provide specialized support including manufacturing and packaging of randomized and blinded supplies, as well as placebo, comparator, and crossover study supplies. We also provide reconciliation drug accountability and destruction services as needed.


Download Drug Product Overview (PDF) Brochure