Commercial production


Agilera has more than 10 years’ experience as a CDMO for the commercial production of radiopharmaceuticals. Our quality assurance system satisfies all requirements for commercial production. It is inspected regularly and has been approved by, for example, the FDA, the Norwegian Medicines Agency and a number of other countries’ authorities.

Our production facilities enable us to carry out everything from small-scale clinical production to full-scale commercial production. We also offer a range of QC services within both chemical and microbiological analyses, including in-house sterility testing.

We offer both sterile and aseptic production and can provide dedicated production suites in a GMP environment and type A isotope laboratories.

Agilera has been granted a commercial manufacturing licence by the Norwegian Medicines Agency and holds the associated GMP certification.

We have established logistics processes that enable efficient and reliable deliveries of commercial products worldwide.

Agilera is an approved manufacturer in the United States, Japan, Europe, Latin America, China and a number of other countries.