This partnership expands the reach of sterile products in the United States
Contract development and manufacturing organisation (CDMO) Recipharm and CDMO Exela Pharma Sciences have collaborated to enhance manufacturing in the United States.
Recipharm will have access to Exela’s North Carolina manufacturing facility, which is accredited by the FDA’s CDER and CBER. This facility manufactures sterile injectable pharmaceuticals in vials and pre-filled syringes.
"We are excited about this strategic alliance with Exela, which significantly enhances our manufacturing footprint in the US,” said Greg Behar, the CEO of Recipharm. “This partnership aligns with our commitment to provide high-quality manufacturing solutions."
Exela’s manufacturing is fully automatic, with capabilities including automatic visual inspection, automated packaging and auto-injector assembly. This makes it suitable for producing GLP-1 drugs, vaccines, peptides, biologics and other sterile products.
The site will transition from its FDA stands to Recipharm’s international compliance practices, extending its reach to ex-US markets for domestic and ex-US pharma and biotech customers. It is also expanding into the production of highly targeted biopharmaceutical drugs such as antibody drug conjugates.
This expansion is supported by Recipharm’s analytical capabilities, manufacturing science and technology support and CDMO’s biologics division ReciBioPharm, which will contribute its advanced therapeutic medicinal product capabilities.
“We are honoured to be Recipharm’s exclusive US partner,” said Phanesh Koneru, Ph.D., LL.M., President & CEO of Exela. “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.”
Exela’s facility will allow Recipharm to stretch its sterile manufacturing capacity in the US, offering over 100 million units production capacity for customers.
