1 October 2026

Farmak International Reaches Key R&D Milestone in Paliperidone 1-Monthly LAI Development

Farmak International has reached an important R&D milestone in its development program for of Paliperidone 1-monthly long-acting injection (LAI)

The development program has included extensive pharmaceutical, analytical and clinical activities supporting this complex prolonged-release injectable. Farmak International has now completed the planned bioequivalence studies, including a single-dose study in healthy volunteers and a multiple-dose study in patients.

The project is now progressing to the next stage of regulatory development, with manufacturing planned at ICM Farmak, Farmak International’s manufacturing site in Barcelona, Spain.

This milestone reflects Farmak Internationalꞌs continued investment in the development and manufacturing of complex sterile injectable medicines in Europe and represents a further step in the regulatory development of Paliperidone LAI.

Farmak International is open to potential B2B collaboration and partnership opportunities, including licensing discussions, in relation to the Paliperidone LAI development program.

About ICM Farmak

ICM Farmak S.L.U. is Farmak International’s manufacturing facility in Spain, focused on the production of sterile injectable medicines. The site specializes in Injectable critical medicines and provides aseptic and terminally sterilized manufacturing and quality control capabilities in compliance with EU GMP requirements.

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