Recipharm - Full Service Contract Development, Manufacturing and Packaging, Clinical Trial Supplies and Biologics Development

Recipharm is one of Europe’s leading pharmaceutical contract development and manufacturing organisations (CDMO). Based in Sweden, we employ approximately 1,400 people across our manufacturing facilities in Sweden, France, Switzerland and the UK, some of which are FDA accredited.

Recipharm is a full service provider that offers formulation development services and commercial manufacturing and packaging solutions for the majority of dose forms including: solid-dose tablets and capsules (including hormones); betalactams and penicillins; sterile vials, ampoules and eye bottles; lyophilisation, semi-solid creams, gels and ointments; dry powder inhalation; granulates and powders. Our biologics facility is able to develop, manufacture and supply recombinant proteins and monoclonal antibodies to phase I and II scale.

Formulation, analytical and packaging development, clinical supplies, stability studies and raw material selection

Operating from a dedicated facility in Stockholm our development team is a group of highly skilled and qualified scientists who have developed many products across most dose forms. The facility benefits from a technical area and GMP area, and also has a fully certified GMP aseptic filling suite for vial production. Our services include formulation development, clinical supplies, analytical development, stability studies to ICH guidelines, packaging development and raw material selection.

Manufacturing services – supply and packaging

With nine manufacturing facilities in Sweden, France, Switzerland and the UK, Recipharm can supply and package most dose forms, including:

• Solid-dose: both tablets and capsules are produced and packaged in a wide range of batch sizes. Recipharm can handle controlled drugs, potent products (including hormones) and organic solvents in granulation and coating. One site benefits from microwave granulation and packaging in a variety of blister materials including PE monoblisters and alu/alu cold form
• Sterile: aseptic filling and terminal sterilisation of vials, ampoules and eyedrop bottles are produced in a wide variety of fill volumes and batch sizes
• Lyophilisation: commercial scale and clinical supplies can be produced in our lyophilisation facility. We can develop and optimise freeze drying cycles according to your requirements
• Dry powder inhalation: from our dedicated facility DPIs can be formulated, manufactured, filled into devices and tested. The facility can manufacture clinical supplies as well as commercial scale material
• Beta-lactams: penicillin antibiotics are produced in a dedicated facility that can manufacture tablets, capsules, dry syrups and package in blisters or bottles
• Semi-solids: creams, gels, ointments and suppositories can be produced in a wide range of presentations including patches, blisters, tubes and syringes
• Granulates and powders: powders can be manufactured in large batch sizes and cost effectively packaged into sachet presentations

Biologics

For projects containing DNA, our pilot plant can develop investigational medicinal products that are suitable for use in humans. Services include: cell line development; upstream and downstream process development; material supply for pre-clinical and clinical use; stability studies; analytical development and product characterisation; and formulation of freeze-dried materials.

Regulatory services and EU gateway release testing

As a full service provider, Recipharm can assist in the development and construction of CMC files. Our broad range of analysts and qualified persons means we can offer EU gateway release testing to customers. Due to our ownership structure, we can often work in ways that our competitors cannot. For example, we take a joint risk and reward approach to projects, and can also offer customised services.