Manufacturing

Manufacturing
Product Description

Alcami offers cGMP manufacturing services with operations ready to scale in tandem with your development and approval milestones. From preclincial through commercial supply, Alcami’s development and manufacturing sites are DEA certified to manage controlled substances, APIs, and other complex compounds. Alcami’s highly integrated operations and manufacturing solutions continue to mitigate supply chain risk, having been successfully inspected by all relevant domestic and international regulatory agencies including the US FDA and EU EMA.

Alcami’s comprehensive development and manufacturing capabilities allow us to offer an equally effective and integrated pharmaceutical development platform to support the best outcomes at every point along your product’s lifecycle. Compound to Clinic® puts formulation, analytical, packaging, and distribution teams in place to help ensure your product moves seamlessly through the development process, made possible with the personal oversight from your dedicated project manager.

Alcami Corporation

  • US
  • 2016
    On CPHI since
  • 1000 - 4999
    Employees
Company types
Biopharmaceutical company
Specifications
  • Selling Points
    Experienced Technicians; Quality Service
  • Supplied from
    United States

Alcami Corporation

  • US
  • 2016
    On CPHI since
  • 1000 - 4999
    Employees
Company types
Biopharmaceutical company

More Products from Alcami Corporation (4)

  • Analytical development

    Product Analytical development

    Alcami offers a fully-integrated analytical method development, method validation, and testing solution with a full complement of advanced analytical and information technologies. From Alcami’s electronic laboratory notebook (ELN) data collection system to its integration with our formulation development, ...
  • Biopharmaceutical development

    Product Biopharmaceutical development

    From initial characterization of drug substance to commercial batch release, each phase of your drug product development requires analytical methods to qualify the product for safety, integrity, strength, purity, and quality.  With these critical attributes in mind, Alcami’s biologics analytical devel...
  • Formulation development

    Product Formulation development

    Alcami’s formulation development team proactively guides your development program every step of the way – from Compound to Clinic.  Our team is adept at solving challenging formulations for new chemical entities (NCEs) and developing high-performance dose forms to meet today’s consumer needs. We offer...
  • Integrated offerings

    Product Integrated offerings

    Alcami is a Us-based, contract development, testing, and manufacturing organization for pharma and biotech companies. Our goal is to support our clients in making their projects go from potential to reality day-after-day.
    Core Capabilities:Sterile-fill finish development and manufacturingO...

Alcami Corporation resources (2)

  • News Alcami to manufacture PharmaTher’s proprietary ketamine products

    The CDMO will supply expertise in GMP sterile fill-finish manufacturing and controlled-substances
  • Brochure Food Studies Brochure

    Alcami is equipped and ready to handle study design and execution of food studies to support a variety of oral solid dosage forms, including tablets, capsules, and suspensions. Our subject matter experts have developed and executed studies using infant formula, yogurt, orange juice, apple sauce, smoothies, and a variety of other foods and drinks.