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Recipharm and Exela have announced that they have entered into an exclusive strategic alliance. The alliance between the two contract development and manufacturing organisations (CDMOs) aims to enhance sterile manufacturing capabilities in the US. As part of the alliance, Recipharm will be able to take advantage of Exela’s state-of-the-art manufacturing plant in Lenoir, NC, US. The plant manufactures sterile injectable pharmaceuticals in vials and pre-filled syringes (PFS), and proved its efficiency and efficacy during the COVID-19 pandemic.

Access to the US Food and Drug Administration (FDA)-accredited plant allows Recipharm to improve its sterile manufacturing footprint in the US, with now over 100 million units capable of being produced to the FDA’s Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) specifications. Part of this manufacturing scope is due to Exela’s advanced manufacturing processes, which include automatic visual inspection, automated packaging and auto-injector assembly. This helps position the plant as a prime option for producing glucagon-like peptide (GLP)-1 drugs, sterile products such as vaccines and biologics, and highly targeted biopharma drugs such as antibody drug conjugates (ADCs).

As part of the agreement, the site will now adopt international compliance practices – in addition to the current FDA-compliant standards – to better align with Recipharm’s operational quality and standards, allowing additional international markets and customers to be targeted. Recipharm will also offer its analytical capabilities, commercial expertise and manufacturing support to Exela. ReciBioPharm, its biologics division, will also collaborate with Exela on its advanced therapeutic medicinal products (ATMP) capabilities.

Greg Behar, CEO of Recipharm, commented: “We are excited about this strategic alliance with Exela, which significantly enhances our manufacturing footprint in the US. This partnership aligns with our commitment to prov ide high quality manufacturing solutions and expand our capabilities in the production of sterile products, such as GLP-1, peptides, biologics, ADCs and other critical pharmaceuticals.”

“Recipharm is a highly respected CDMO with worldw ide reach. We are honoured and excited to be Recipharm’s exclusive US partner. This collaboration offers a unique and efficient CDMO platform for biopharma customers that seek to participate in both US and EU markets and are looking for scale, speed and versatility with experience in delivering complex projects,” added Phanesh Koneru PhD LLM, president and CEO of Exela.

Recipharm is a CDMO with facilities in Sweden, France, Germany, Italy, Spain, Portugal, India and the UK. Its headquarters are in Sweden. Exela is a software comapany that specialises in business process automation, based in the US.