Commercial Drug Product Manufacture

Commercial Drug Product Manufacture
Product Description

Over 40 years’ Experience Manufacturing Solid, Oral Dosage Forms
Scaling up from our development services to full scale commercial drug product manufacture or transferring existing commercial products we can meet your commercial drug product manufacturing requirements.

Our range of commercial scale dry blending and wet granulation technology supports the commercial drug product manufacture of:

Tablets

    • Immediate and modified release
    • Uncoated and coated (including enteric coating)
Capsules
    • Hard gelatin capsules (powders, pellets)
Powders
    • Granules
    • Oral powders for reconstitution
With blend sizes from 10kgs up to 2.5 tons, our range of state-of-the-art processing equipment can flex to the batch size requirements of your particular product needs.

Ensuring That Your Products Meet Specifications
We are MHRA licensed and have been successfully inspected by the FDA, Pmda, ANVISA, Turkish Ministry of Health and South Korea FDA. With UK Home Office approval, we are also licensed for the storage and processing of controlled drugs (schedules II-V). A quality led environment is the foundation of our operations and we impose comprehensive standard operating procedures, rigorous training and a range of process controls.

Customised Solutions
To support operational activities, we have a dedicated in-house engineering team who provide equipment maintenance and calibration, tooling design and machine prototype manufacture. With dedicated specialists in place, we are able to facilitate the rapid turnaround of tailored solutions and provide equipment designed to meet the unique requirements of each and every project.

Almac Group Ltd

  • GB
  • 2015
    On CPHI since
  • 4
    Certificates
  • 5000+
    Employees
Company types
CMO/CDMO
Contract Service
Manufacturer/Innovator
Packaging supplier/manufacturer
Primary activities
Analytical Services
API Producer
Biopharmaceutical
Chemical Development
Contract Manufacturer
Custom Manufacturing/Custom Synthesis
Fine Chemicals Company
Intermediates Manufacturer
Laboratory Services
Other
Packaging & drug delivery
Supply Chain
Transport/Logistics/Distribution

Almac Group Ltd

  • GB
  • 2015
    On CPHI since
  • 4
    Certificates
  • 5000+
    Employees
Company types
CMO/CDMO
Contract Service
Manufacturer/Innovator
Packaging supplier/manufacturer
Primary activities
Analytical Services
API Producer
Biopharmaceutical
Chemical Development
Contract Manufacturer
Custom Manufacturing/Custom Synthesis
Fine Chemicals Company
Intermediates Manufacturer
Laboratory Services
Other
Packaging & drug delivery
Supply Chain
Transport/Logistics/Distribution

More Products from Almac Group Ltd (15)

  • Pharmaceutical Development - Late Phase

    Product Pharmaceutical Development - Late Phase

    Enabling Confidence and Security in the Supply Chain

    Specialising in solid oral dosage forms, Almac has the technical experience and knowledge to develop robust formulations and manufacturing processes.

    We have assisted many of our clients in the development of both immediate and mo...
  • Physical Sciences

    Product Physical Sciences

    We are experts in solid state chemistry.Through the creation of synergy between solid state chemistry and formulation development, our experienced scientists have the ability to 
  • API Services, Chemical Development & Manufacture

    Product API Services, Chemical Development & Manufacture

    Almac’s strength in API development and manufacture is proven by being the partner of choice for many pharma and biotech companies seeking integrated drug development solutions from molecule to market.

    Our technical expertise and extensive facilities enable us to offer integrated API contract ma...
  • 14C Radiolabelling

    Product 14C Radiolabelling

    Almac has extensive experience in the synthesis and analysis of stable (non radio-active) and 14C isotope labelled compounds – from drug discovery through to launch – we can label any compound at any stage, including small molecules, peptides and larger bio molecules.

    Our custom radiolabell...
  • Analytical Services

    Product Analytical Services

    Our state-of-the-art analytical testing labs support drug substance (API) and drug product (finished product) analytics across all phases of clinical development and into commercial release.

    We employ over 170 highly skilled analysts working in GMP environments across the UK, Europe, and the...
  • Biocatalysis Solutions

    Product Biocatalysis Solutions

    BBiocatalysts are essential tools in chemical synthesis, particularly in the synthesis of pharmaceutical and fine chemical targets.As highly selective catalysts, they offer a direct and simple way to synthesise complex achiral and chiral compounds. The application of biocatalysts in the pharmaceutical and ...
  • Commercial Packaging

    Product Commercial Packaging

    We offer a wide range of commercial packaging solutions to meet your needs, from initial artwork and pack design, to commercial packaging and distribution.

    From our UK and US commercial packaging facilities, we are able to serve global markets. We are MHRA and FDA licensed an...
  • Commercial Storage and Distribution

    Product Commercial Storage and Distribution

    Complementing our commercial manufacturing and packaging services, we provide a range of commercial storage and distribution solutions for solid oral dosage forms and sterile biopharmaceuticals, for both niche / orphan drug products and large scale commercial market volumes.

    Utilising our bespok...
  • Peptide and Protein Technology

    Product Peptide and Protein Technology

    Almac’s peptide and protein technology offering is a key component within our suite of services.  We offer a complete range of peptide and protein services from catalogue products through to GMP manufacture from early phase to commercial launch.  We have a proven track record in high quality supp...
  • Pharmaceutical Development - Early Phase

    Product Pharmaceutical Development - Early Phase

    Almac’s experienced formulation scientists can develop a range of oral dose formulations for early stage clinical trials.

    With both non-GMP and GMP facilities, flexible and efficient solutions are provided to develop a fit-for-purpose formulation for your early phase clinical trial.
    ...
  • Pharmaceutical Product Launch and Distribution

    Product Pharmaceutical Product Launch and Distribution

    Pharmaceutical Product Launch and Distribution
    Having successfully partnered in the launch of 15 significant orphan and niche drug products into the EU market over the last 3 years, Almac is the industry leader for Pharmaceutical Product Launch and Distribution.
    q...
  • Serialisation

    Product Serialisation

    Serialisation and Track & Trace
    Addressing evolving global serialisation legislation, Almac’s expert multi-disciplinary serialisation team lead the way in supporting clients in developing their serialisation strategies to GS1 standards.

    ...

Almac Group Ltd resources (17)