Drug Product Manufacturing

Drug Product Manufacturing
Formulation Development
Oral Solid Dose Manufacturing
Sterile Fill Finish

Scalable cGMP Drug Product Manufacturing Solutions

Alcami’s cGMP drug product manufacturing services feature operations ready to scale in tandem with your drug development and approval milestones. From preclinical through commercial supply, our development and manufacturing sites are DEA-certified to manage controlled substances, APIs, and other complex compounds. Our highly integrated operations and manufacturing solutions, successfully inspected by regulatory agencies such as the U.S. FDA and EU EMA, continue to mitigate supply chain risk.

We have played a crucial role in the commercialization of over 50 programs, with nearly one-third of our active projects currently in the late stages of development (Phase III/Registration). We support development programs from discovery and Pre-Clinical stages through to commercialization, ensuring seamless progression at every phase.


Drug Product Manufacturing Capabilities

We offer an effective, integrated pharmaceutical development platform to support the best outcomes at every point along your product’s lifecycle. Alcami puts formulation, analytical, packaging, and distribution teams in place to help ensure your product moves seamlessly through the development process. Your dedicated project manager has personal oversight — and can assist you with both lab services and storage as your product makes it way through development.

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    Formulation Development

  • Early-phase accelerated programs for NCEs

  • Generic drug development (ANDAs and ANADAs)

  • Technical transfer plan with comprehensive PFMEA / risk & gap assessment

  • Thawing, mixing, & filling studies

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    Packaging & Labeling

  • Randomization & blinding studies

  • Reconciliation drug accountability

  • Serialization & aggregation

  • Destruction services, where needed